SYRINGE 1ML LL W/O DN
Report
- Report Number
- 1213809-2020-00505
- Event Type
- Malfunction
- Date Received
- August 1, 2020
- Date of Event
- May 6, 2020
- Report Date
- August 14, 2020
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096283
- PMA / PMN Number
- K941562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: THREE PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICTED TWO 1ML LL SYRINGES IN SEPARATE CUSTOMER PACKAGES WITH DIFFERENT CUSTOMER LOT NUMBERS. IT WAS NOT CLEAR WHICH BD LOT # CORRESPONDED TO WHICH SAMPLE. ONE SYRINGE WAS OBSERVED TO HAVE A SKEWED SCALE OUTSIDE ACCEPTABLE LIMITS WITH ITS ZERO LINE AT A VISIBLY HIGHER POSITION THAN DESIGNED. ONE SYRINGE APPEARED TO HAVE CORRECT SCALE MARKINGS. THE ZERO LINE WAS AT THE EDGE BETWEEN THE BARREL AND LUER COLLAR. FROM THE ONE ANGLE THE PICTURE WAS TAKEN FROM, IT WAS NOT POSSIBLE TO TELL WHETHER THERE WERE ANY ISSUES WITH THE SCALE PLACEMENT IN THIS SAMPLE. PHYSICAL SAMPLE WOULD BE NECESSARY FOR EVALUATION AND TESTING. MARKING AND ASSEMBLY DHR WERE CHECKED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. MARKER ISSUES WERE RECORDED DURING ONE OF THE SUB-ASSEMBLY BATCHES. BATCHES 9003923 AND 9064555 WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. POTENTIAL ROOT CAUSE FOR THE SCALE MARKING DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. A BARREL MISFEED LIKELY RESULTED IN THE SKEW OF THE SCALE, INCLUDING THE OFFSET OF THE ZERO LINE. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 9003923 AND 9064555 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10
IT WAS REPORTED THAT SYRINGE 1ML LL W/O DN HAS A SCALE MARKINGS MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SCALE MARKINGS ARE MISALIGNED AND ELEVATED OFF THE HUB WHICH MAY APPEAR AS IF YOU'RE INJECTING A LARGER VOLUME. COMPLAINT DESCRIPTION PER E-MAIL RECEIVED ON 07/13/2020 MD APOLOGIES, THE TITLE OF THE ORIGINAL EMAIL CONTAINED THE INCORRECT REGENERON COMPLAINT NUMBERS AND MISSED ONE REGENERON COMPLAINT NUMBER. THE COMPLAINT DESCRIPTION, RECEIVED IMAGES, AND RETURNED COMPONENT STATUS IN THE TABLE BELOW ARE THE SAME FOR REGENERON COMPLAINTS (B)(4). HERE¿S A TABLE TO HELP CLARIFY AND ORGANIZE THE INFORMATION. REGEMC-41584-PC VERSION 1 RECEIVED 06MAY2020: ON 06-MAY-2020, REGENERON MEDICAL INFORMATION WAS NOTIFIED OF A PRODUCT COMPLAINT VIA PHONE BY THE REPORTER WHO WAS A PHARMACIST. THE REPORTER DENIED ANY MISSED DOSES OR ADVERSE EVENTS OCCURRED. PER THE REPORTER, THERE HAVE BEEN MULTIPLE OCCASIONS WHERE THE GRADUATIONS (LINES) ON THE SYRINGE ARE MISALIGNED. HE SAID THE GRADUATIONS USUALLY START AT THE BASE OF THE HUB BUT THE ISSUE IS THAT SOME SYRINGES HAVE GRADUATIONS THAT ARE 1MM OR 2MM "ELEVATED OFF THE HUB" WHICH MAY APPEAR AS IF "YOU MAY BE INJECTING A LARGER VOLUME." THE REPORTER SAID THIS ISSUE HAS OCCURRED "ACROSS 10 DIFFERENT SITES" (CLINICS) OF HIS ORGANIZATION. HE SAID AT LEAST 2 OCCASIONS OCCURRED ON 06-MAY-2020 (ONE AT THE BEACHWOOD SITE AND ONE AT THE MAIN CAMPUS). THE REPORTER SAID THE ISSUE WAS ALWAYS CAUGHT BEFORE THE PRODUCT COULD BE USED. NONE OF THE AFFECTED MEDICATIONS WERE USED. THE PATIENTS SUCCESSFULLY RECEIVED DOSES FROM NEW EYLEA KITS; THEREFORE, THERE WERE NO MISSED DOSES OR ADVERSE EVENTS. THE REPORTER CONFIRMED HE DID NOT HAVE ANY PRODUCTS AVAILABLE FOR RETURN. HE SAID SOME OF THE CLINICS MIGHT HAVE PRODUCT AVAILABLE FOR RETURN; HOWEVER, HE DID NOT KNOW WHICH COMPONENTS. THE REPORTER ALSO SAID SOME OF AFFECTED PRODUCTS MIGHT HAVE BEEN DISCARDED. HE DOES NOT KNOW WHICH CLINICS HAVE PRODUCT AVAILABLE FOR RETURN AND THIS COULD TAKE DAYS TO OBTAIN SINCE SOME CLINICS MAY NOT BE OPEN DUE TO THE COVID-19 SITUATION. PER THE REPORTER, HE AT LEAST KNOWS THERE WERE 2 LOT NUMBERS INVOLVED WITH THIS ISSUE: 8148200321 AND 8148200289. IT WAS UNKNOWN IF THESE PRODUCTS WERE AVAILABLE FOR RETURN AS THEY WERE FROM ANOTHER CLINIC. THE REPORTER SAID HE WILL SEND PHOTOGRAPHS OF 2 SYRINGES WITH THE ISSUE. HE SAID IN THE PHOTOGRAPHS, ONE SYRINGE HAS THE GRADUATIONS STARTING AT THE LUER LOCK AREA AND THE OTHER SYRINGE STARTS CLOSER TO THE HUB. THE REPORTER SAID THE INDIVIDUAL CLINICS MIGHT CALL REGENERON MEDICAL INFORMATION TO START THEIR OWN RETURN/REPLACEMENT PROCESS IF THERE WERE PRODUCTS STILL AVAILABLE FOR RETURN OR IF A REPLACEMENT WAS NEEDED. THE REPORTER SAID HIS MAIN REASON FOR CALLING MEDICAL INFORMATION WAS SO REGENERON QUALITY COULD BE MADE AWARE OF THE ISSUE. ON 06-MAY-2020, REGENERON MEDICAL INFORMATION RECEIVED AN EMAIL FROM THE REPORTER CONTAINING PHOTOGRAPHS OF THE PRODUCT. PLEASE REFER TO THE ATTACHED SOURCE DOCUMENT FOR FURTHER INFORMATION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. IS THE DEFECTIVE VIAL OR COMPONENT AVAILABLE FOR RETRIEVAL? NO NOTE: THREE IMAGES RECEIVED. ONE SHOWING THE LOT NUMBERS. REGEMC-41584-PC VERSION 1 RECEIVED 08MAY2020: CF 07MAY2020 VERSION 2 (08-MAY-2020, MTABUCBUC): ON 08-MAY-2020, REGENERON MEDICAL INFORMATION RECEIVED THE FOLLOWING REQUEST FROM REGENERON QA, "WILL YOU PLEASE FOLLOW UP WITH THE REPORTER ASKING IF THEY COULD CONTACT THE OTHER SITES THAT HAVE THIS SYRINGE ISSUE AND HAVE THEM REQUEST LOT NUMBERS AND THE RETURN AVAILABILITY OF EACH ISSUE?" ON 08-MAY-2020, MEDICAL INFORMATION MADE AN OUTBOUND CALL TO THE REPORTER TO OBTAIN THE REQUESTED INFORMATION. PER THE REPORTER, THE SITES WHO EXPERIENCED THE SAME SYRINGE ISSUE WERE ALREADY CONTACTING REGENERON MEDICAL INFORMATION TO INITIATE THEIR OWN RETURN/REPLACEMENT REQUESTS. THE REPORTER DID NOT KNOW WHICH SITES HAVE CONTACTED MEDICAL INFORMATION AND HE DID NOT HAVE THE REGEMC CASE NUMBERS. HE SAID HE WOULD NOT BE ABLE TO OBTAIN THE CASE NUMBERS SINCE SO MANY OFFICES WERE INVOLVED AND THEY WERE EACH CONTACTING MEDICAL INFORMATION ON THEIR OWN. FURTHERMORE, THE REPORTER STATED HE DOES NOT KNOW WHICH SITES HAVE PRODUCT COMPONENTS AVAILABLE FOR RETURN SINCE EACH OFFICE IS TAKING CARE OF THE ISSUE ON THEIR OWN. HE CONFIRMED, TO HIS KNOWLEDGE, THE ONLY LOT NUMBERS ASSOCIATED WITH THIS ISSUE WERE THE TWO LOT NUMBERS ORIGINALLY INCLUDED IN THIS REPORT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. QUESTIONS ASKED FOR ALL COMPLAINTS: 1. WAS THE PRODUCT STORED PROPERLY PRIOR TO DOSE PREPARATION? YES 2. IS THE EVENT A RESULT OF IMPROPER SHIPPING? NO 3. IS THE EVENT A RESULT OF A STORAGE ISSUE AT THE PHYSICIAN'S OFFICE OR PATIENT HOME (FOR EXAMPLE: REFRIGERATOR MALFUNCTION, STORED AT ROOM TEMP, ETC.)? NO 4. WAS THE PRODUCT PREPARED FOR ADMINISTRATION? YES 5. WAS THE PRODUCT ADMINISTERED TO THE PATIENT? NO 6. IS THE EVENT A RESULT OF A NATURAL DISASTER? NO"
MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9064555, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-12, MEDICAL DEVICE LOT #: 9003923, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-24, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT SYRINGE 1ML LL W/O DN HAS A SCALE MARKINGS MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SCALE MARKINGS ARE MISALIGNED AND ELEVATED OFF THE HUB WHICH MAY APPEAR AS IF YOU'RE INJECTING A LARGER VOLUME. COMPLAINT DESCRIPTION: PER E-MAIL RECEIVED ON 07/13/2020 MD. APOLOGIES, THE TITLE OF THE ORIGINAL EMAIL CONTAINED THE INCORRECT REGENERON COMPLAINT NUMBERS AND MISSED ONE REGENERON COMPLAINT NUMBER. THE COMPLAINT DESCRIPTION, RECEIVED IMAGES, AND RETURNED COMPONENT STATUS IN THE TABLE BELOW ARE THE SAME FOR REGENERON COMPLAINTS (B)(4). HERE¿S A TABLE TO HELP CLARIFY AND ORGANIZE THE INFORMATION. (B)(4) VERSION 1 RECEIVED (B)(6) 2020: ON (B)(6) 2020, (B)(6) MEDICAL INFORMATION WAS NOTIFIED OF A PRODUCT COMPLAINT VIA PHONE BY THE REPORTER WHO WAS A PHARMACIST. THE REPORTER DENIED ANY MISSED DOSES OR ADVERSE EVENTS OCCURRED. PER THE REPORTER, THERE HAVE BEEN MULTIPLE OCCASIONS WHERE THE GRADUATIONS (LINES) ON THE SYRINGE ARE MISALIGNED. HE SAID THE GRADUATIONS USUALLY START AT THE BASE OF THE HUB BUT THE ISSUE IS THAT SOME SYRINGES HAVE GRADUATIONS THAT ARE 1MM OR 2MM "ELEVATED OFF THE HUB" WHICH MAY APPEAR AS IF "YOU MAY BE INJECTING A LARGER VOLUME." THE REPORTER SAID THIS ISSUE HAS OCCURRED "ACROSS 10 DIFFERENT SITES" (CLINICS) OF HIS ORGANIZATION. HE SAID AT LEAST 2 OCCASIONS OCCURRED ON (B)(6) 2020 (ONE AT THE (B)(6) SITE AND ONE AT THE MAIN CAMPUS). THE REPORTER SAID THE ISSUE WAS ALWAYS CAUGHT BEFORE THE PRODUCT COULD BE USED. NONE OF THE AFFECTED MEDICATIONS WERE USED. THE PATIENTS SUCCESSFULLY RECEIVED DOSES FROM NEW EYLEA KITS; THEREFORE, THERE WERE NO MISSED DOSES OR ADVERSE EVENTS. THE REPORTER CONFIRMED HE DID NOT HAVE ANY PRODUCTS AVAILABLE FOR RETURN. HE SAID SOME OF THE CLINICS MIGHT HAVE PRODUCT AVAILABLE FOR RETURN; HOWEVER, HE DID NOT KNOW WHICH COMPONENTS. THE REPORTER ALSO SAID SOME OF AFFECTED PRODUCTS MIGHT HAVE BEEN DISCARDED. HE DOES NOT KNOW WHICH CLINICS HAVE PRODUCT AVAILABLE FOR RETURN AND THIS COULD TAKE DAYS TO OBTAIN SINCE SOME CLINICS MAY NOT BE OPEN DUE TO THE COVID-19 SITUATION. PER THE REPORTER, HE AT LEAST KNOWS THERE WERE 2 LOT NUMBERS INVOLVED WITH THIS ISSUE: 8148200321 AND 8148200289. IT WAS UNKNOWN IF THESE PRODUCTS WERE AVAILABLE FOR RETURN AS THEY WERE FROM ANOTHER CLINIC. THE REPORTER SAID HE WILL SEND PHOTOGRAPHS OF 2 SYRINGES WITH THE ISSUE. HE SAID IN THE PHOTOGRAPHS, ONE SYRINGE HAS THE GRADUATIONS STARTING AT THE LUER LOCK AREA AND THE OTHER SYRINGE STARTS CLOSER TO THE HUB. THE REPORTER SAID THE INDIVIDUAL CLINICS MIGHT CALL (B)(6) MEDICAL INFORMATION TO START THEIR OWN RETURN/REPLACEMENT PROCESS IF THERE WERE PRODUCTS STILL AVAILABLE FOR RETURN OR IF A REPLACEMENT WAS NEEDED. THE REPORTER SAID HIS MAIN REASON FOR CALLING MEDICAL INFORMATION WAS SO (B)(6) QUALITY COULD BE MADE AWARE OF THE ISSUE. ON (B)(6) 2020, (B)(6) MEDICAL INFORMATION RECEIVED AN EMAIL FROM THE REPORTER CONTAINING PHOTOGRAPHS OF THE PRODUCT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. IS THE DEFECTIVE VIAL OR COMPONENT AVAILABLE FOR RETRIEVAL? NO NOTE: THREE IMAGES RECEIVED. ONE SHOWING THE LOT NUMBERS. (B)(4) VERSION 1 RECEIVED 08MAY2020: CF 07MAY2020 VERSION 2 (08-MAY-2020, (B)(4)): ON 08-MAY-2020, (B)(6) MEDICAL INFORMATION RECEIVED THE FOLLOWING REQUEST FROM (B)(6) QA, "WILL YOU PLEASE FOLLOW UP WITH THE REPORTER ASKING IF THEY COULD CONTACT THE OTHER SITES THAT HAVE THIS SYRINGE ISSUE AND HAVE THEM REQUEST LOT NUMBERS AND THE RETURN AVAILABILITY OF EACH ISSUE?" ON 08-MAY-2020, MEDICAL INFORMATION MADE AN OUTBOUND CALL TO THE REPORTER TO OBTAIN THE REQUESTED INFORMATION. PER THE REPORTER, THE SITES WHO EXPERIENCED THE SAME SYRINGE ISSUE WERE ALREADY CONTACTING (B)(6) MEDICAL INFORMATION TO INITIATE THEIR OWN RETURN/REPLACEMENT REQUESTS. THE REPORTER DID NOT KNOW WHICH SITES HAVE CONTACTED MEDICAL INFORMATION AND HE DID NOT HAVE THE (B)(6) CASE NUMBERS. HE SAID HE WOULD NOT BE ABLE TO OBTAIN THE CASE NUMBERS SINCE SO MANY OFFICES WERE INVOLVED AND THEY WERE EACH CONTACTING MEDICAL INFORMATION ON THEIR OWN. FURTHERMORE, THE REPORTER STATED HE DOES NOT KNOW WHICH SITES HAVE PRODUCT COMPONENTS AVAILABLE FOR RETURN SINCE EACH OFFICE IS TAKING CARE OF THE ISSUE ON THEIR OWN. HE CONFIRMED, TO HIS KNOWLEDGE, THE ONLY LOT NUMBERS ASSOCIATED WITH THIS ISSUE WERE THE TWO LOT NUMBERS ORIGINALLY INCLUDED IN THIS REPORT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. QUESTIONS ASKED FOR ALL COMPLAINTS: WAS THE PRODUCT STORED PROPERLY PRIOR TO DOSE PREPARATION? YES. IS THE EVENT A RESULT OF IMPROPER SHIPPING? NO. IS THE EVENT A RESULT OF A STORAGE ISSUE AT THE PHYSICIAN'S OFFICE OR PATIENT HOME (FOR EXAMPLE: REFRIGERATOR MALFUNCTION, STORED AT ROOM TEMP, ETC.)? NO. WAS THE PRODUCT PREPARED FOR ADMINISTRATION? YES. WAS THE PRODUCT ADMINISTERED TO THE PATIENT? NO. IS THE EVENT A RESULT OF A NATURAL DISASTER? NO".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818181 | SYRINGE 1ML LL W/O DN | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309628 | SEE H.10. | 30382903096283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |