BD¿ INSULIN SYRINGE WITH NEEDLE
Report
- Report Number
- 1920898-2018-00464
- Event Type
- Malfunction
- Date Received
- June 28, 2018
- Date of Event
- June 1, 2018
- Report Date
- August 23, 2018
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMI
- UDI-DI
- 00311917025285
- PMA / PMN Number
- K955235
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121513. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [200696348, 200692505, 200692504, 200696347, 200696533] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7121513. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.
ADDITIONAL INFORMATION: SAMPLES WERE RECEIVED FOR EVALUALTION. CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: UNKNOWN. EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) 1/2CC, 8MM, 30G WALGREENS SYRINGES IN AN OPEN POLY BAG FROM LOT # 7121513. CUSTOMER STATES THAT THERE WERE THREE SYRINGES WITH CLEAR LIQUID AT THE TIP OF THE NEEDLE. ALL RETURNED SYRINGES WERE EXAMINED AND NO LIQUID OR ANY OTHER FOREIGN MATTER WAS OBSERVED ON OR ON THE SAMPLES. HOWEVER, WHEN THE PLUNGER RODS WERE FULLY DEPRESSED, A SMALL, CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA OF 2 OUT OF 4 SAMPLES. A SMALL PORTION OF THE CLEAR LIQUID WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. WHEN THE PLUNGER IS FULLY DEPRESSED, THE SILICONE GETS DISTRIBUTED ALONG THE BARREL ROOF AND WALLS, ENSURING A LUBRICATED SURFACE FOR THE PLUNGER TO MOVE AGAINST. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. CAPA # 56537 AND SITUATION ANALYSIS # BDDC-16-871-SA HAVE BEEN OPENED TO ADDRESS THIS ISSUE. SAMPLES WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) ON 03AUG2018 FOR FURTHER REVIEW. ON 07AUG2018, HOLDREGE RECEIVED FOUR (4) 0.5ML, 8MM, 30 G SYRINGES IN OPENED POLYBAG FROM BATCH # 7121513. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION OF QE AA, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. ONLY 1 OF THE 4 EXHIBITED A CLEAR DROPLET OF MATERIAL THAT CAME OUT THE END OF THE CANNULA. POSSIBLE ROOT CAUSE: ASSOCIATE DOES NOT DEGAS SILICONE AFTER REFILLING THE TANKS. THE SILICONE VOLUME ON THE PUMP IS A PARAMETER THAT IS BEING ADJUSTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121513. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER ON NEEDLE ON LOT # 7121513. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THREE BD¿ INSULIN SYRINGE WITH NEEDLES WERE FOUND WITH CLEAR LIQUID AT THE TIP OF THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THREE BD¿ INSULIN SYRINGE WITH NEEDLES WERE FOUND WITH CLEAR LIQUID AT THE TIP OF THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THREE BD¿ INSULIN SYRINGE WITH NEEDLES WERE FOUND WITH CLEAR LIQUID AT THE TIP OF THE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491094 | BD¿ INSULIN SYRINGE WITH NEEDLE | INSULIN SYRINGE WITH NEEDLE | FMI | BD MEDICAL - DIABETES CARE | 7121513 | 00311917025285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |