BD 1ML SYRINGE LUER-LOK TIP
Report
- Report Number
- 1213809-2019-01305
- Event Type
- Malfunction
- Date Received
- December 26, 2019
- Date of Event
- December 9, 2019
- Report Date
- February 25, 2020
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096283
- PMA / PMN Number
- K941562
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION. B.5. DESCRIBE EVENT OR PROBLEM: MATERIAL NO.: 309628; BATCH NO.: 8211619 & 8220910. IT WAS REPORTED THAT DURING USE OF THE BD 1ML SYRINGE LUER-LOK¿ TIP THE MEDICATION GETS CLOGGED AND STOPS AT THE .2 MARK ON THE SYRINGE. DISTRIBUTOR CALLED AND STATED THAT HE HAS HAD SEVERAL COMPLAINTS REGARDING PRODUCT 309628. HIS CUSTOMER'S HAVE BEEN USING THE PRODUCT TO GIVE FLU VACCINES, BUT ARE FINDING THAT THE MEDICATION GETS CLOGGED AND STOPS AT THE .2 MARK ON THE SYRINGE. PATIENTS ARE NOT GETTING THE FULL VACCINATION. DISTRIBUTOR STATED THAT THERE ARE NO CONFIRMED NUMBER OF OCCURRENCES NOR ANY SPECIFIC DATES. HE CURRENTLY HAS NO SAMPLES, BUT STATED HE WOULD ASK HIS CUSTOMERS TO KEEP THEM IF THEY HAVE THEM. THE FOLLOWING INFORMATION WAS PROVIDED. WAS THERE MULTIPLE PATIENT INVOLVEMENT? NO. ARE PATIENT IDENTIFIERS AVAILABLE? NO. WHAT IS THE DATE OF EVENT(S) PER BATCH/LOT NUMBER? (B)(6) 2019. WHAT IS THE OCCURRENCE QUANTITY PER BATCH/LOT NUMBER? ABOUT 5-10. WAS THE COURSE OF TREATMENT CHANGED? YES. ALL THE SYRINGES WERE REMOVED FROM INVENTORY AND STOCK. THEN PLACED IN OFFICE MANAGERS OFFICE SO STAFF DO NOT USE. GIVEN TO SUPPLIER TO RETURN AND/OR DISPOSE OF. WAS THERE MEDICAL INTERVENTION? NO ¿ NO PATIENT OR STAFF NEEDLE STICK INJURIES SUSTAINED. ARE SAMPLES RELATED TO THE BATCH AVAILABLE FOR INVESTIGATION? NO SAMPLES (DEFECTIVE SYRINGES) RELATED TO THE BATCH AVAILABLE FOR INVESTIGATION AS THEY WERE DISPOSED OF APPROPRIATELY IN SHARPS CONTAINER. SPOKE WITH CUSTOMER 12-FEB-2020 TO GAIN CLARIFICATION IF A BD NEEDLE WAS INVOLVED. THE NEEDLE WAS A MAGELLAN NEEDLE WHICH WAS ATTACHED TO THE SYRINGE. CUSTOMER USED SAME NEEDLE THAT THEY THOUGHT MIGHT HAVE BEEN CLOGGED ON A NEW SYRINGE AND HAD NO ISSUES. F.10 DEVICE CODES: 1354. H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.
B.3. DATE OF EVENT: (B)(6) 2019.
MATERIAL NO.: 309628; BATCH NO.: 8211619 & 8220910. IT WAS REPORTED THAT DURING USE OF THE BD 1ML SYRINGE LUER-LOK¿ TIP THE MEDICATION GETS CLOGGED AND STOPS AT THE .2 MARK ON THE SYRINGE. DISTRIBUTOR CALLED AND STATED THAT HE HAS HAD SEVERAL COMPLAINTS REGARDING PRODUCT 309628. HIS CUSTOMER'S HAVE BEEN USING THE PRODUCT TO GIVE FLU VACCINES, BUT ARE FINDING THAT THE MEDICATION GETS CLOGGED AND STOPS AT THE .2 MARK ON THE SYRINGE. PATIENTS ARE NOT GETTING THE FULL VACCINATION. DISTRIBUTOR STATED THAT THERE ARE NO CONFIRMED NUMBER OF OCCURRENCES NOR ANY SPECIFIC DATES. HE CURRENTLY HAS NO SAMPLES, BUT STATED HE WOULD ASK HIS CUSTOMERS TO KEEP THEM IF THEY HAVE THEM. THE FOLLOWING INFORMATION WAS PROVIDED. WAS THERE MULTIPLE PATIENT INVOLVEMENT? NO. ARE PATIENT IDENTIFIERS AVAILABLE? NO. WHAT IS THE DATE OF EVENT(S) PER BATCH/LOT NUMBER? (B)(6) 2019. WHAT IS THE OCCURRENCE QUANTITY PER BATCH/LOT NUMBER? ABOUT 5-10. WAS THE COURSE OF TREATMENT CHANGED? YES. ALL THE SYRINGES WERE REMOVED FROM INVENTORY AND STOCK. THEN PLACED IN OFFICE MANAGERS OFFICE SO STAFF DO NOT USE. GIVEN TO SUPPLIER TO RETURN AND/OR DISPOSE OF. WAS THERE MEDICAL INTERVENTION? NO ¿ NO PATIENT OR STAFF NEEDLE STICK INJURIES SUSTAINED. ARE SAMPLES RELATED TO THE BATCH AVAILABLE FOR INVESTIGATION? NO SAMPLES (DEFECTIVE SYRINGES) RELATED TO THE BATCH AVAILABLE FOR INVESTIGATION AS THEY WERE DISPOSED OF APPROPRIATELY IN SHARPS CONTAINER. SPOKE WITH CUSTOMER 12-FEB-2020 TO GAIN CLARIFICATION IF A BD NEEDLE WAS INVOLVED. THE NEEDLE WAS A MAGELLAN NEEDLE WHICH WAS ATTACHED TO THE SYRINGE. CUSTOMER USED SAME NEEDLE THAT THEY THOUGHT MIGHT HAVE BEEN CLOGGED ON A NEW SYRINGE AND HAD NO ISSUES.
MATERIAL NO.: 309628, BATCH NO.: 8211619 & 8220910. IT WAS REPORTED THAT DURING USE OF THE BD 1ML SYRINGE LUER-LOK¿ TIP THE MEDICATION GETS CLOGGED AND STOPS AT THE .2 MARK ON THE SYRINGE. DISTRIBUTOR CALLED AND STATED THAT HE HAS HAD SEVERAL COMPLAINTS REGARDING PRODUCT 309628. HIS CUSTOMER'S HAVE BEEN USING THE PRODUCT TO GIVE FLU VACCINES, BUT ARE FINDING THAT THE MEDICATION GETS CLOGGED AND STOPS AT THE .2 MARK ON THE SYRINGE. PATIENTS ARE NOT GETTING THE FULL VACCINATION. DISTRIBUTOR STATED THAT THERE ARE NO CONFIRMED NUMBER OF OCCURRENCES NOR ANY SPECIFIC DATES. HE CURRENTLY HAS NO SAMPLES, BUT STATED HE WOULD ASK HIS CUSTOMERS TO KEEP THEM IF THEY HAVE THEM.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8211619. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-10-01. MEDICAL DEVICE LOT #: 8220910. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-08-21. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.
MATERIAL NO.: 309628 BATCH NO.: 8211619 & 8220910. IT WAS REPORTED THAT DURING USE OF THE BD 1ML SYRINGE LUER-LOK¿ TIP THE MEDICATION GETS CLOGGED AND STOPS AT THE .2 MARK ON THE SYRINGE. DISTRIBUTOR CALLED AND STATED THAT HE HAS HAD SEVERAL COMPLAINTS REGARDING PRODUCT 309628. HIS CUSTOMER'S HAVE BEEN USING THE PRODUCT TO GIVE FLU VACCINES, BUT ARE FINDING THAT THE MEDICATION GETS CLOGGED AND STOPS AT THE .2 MARK ON THE SYRINGE. PATIENTS ARE NOT GETTING THE FULL VACCINATION. DISTRIBUTOR STATED THAT THERE ARE NO CONFIRMED NUMBER OF OCCURRENCES NOR ANY SPECIFIC DATES. HE CURRENTLY HAS NO SAMPLES, BUT STATED HE WOULD ASK HIS CUSTOMERS TO KEEP THEM IF THEY HAVE THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1316983 | BD 1ML SYRINGE LUER-LOK TIP | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309628 | SEE SECTION H.10 | 30382903096283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |