BD SYRINGE LUER-LOK TIP
Report
- Report Number
- 1213809-2019-00930
- Event Type
- Malfunction
- Date Received
- September 16, 2019
- Date of Event
- August 29, 2019
- Report Date
- October 28, 2019
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903009122
- PMA / PMN Number
- K980987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: AN ADDITIONAL BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THERE WAS EXCESS SILICONE FOUND IN THE BD SYRINGE LUER-LOK¿ TIP PISTON BEFORE USE. LOT #'S 9142984 AND 9142988 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TO MUCH SILICONE OIL IN PISTON" THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9142984 D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31 H.4. DEVICE MANUFACTURE DATE: 2019-05-22 D.4. MEDICAL DEVICE LOT #: 9142988 D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31 H.4. DEVICE MANUFACTURE DATE: 2019-05-22.
H.6. INVESTIGATION SUMMARY: EIGHT 10ML SYRINGES WERE RECEIVED AND EVALUATED. SEVEN WERE LOOSE AND ONE WAS IN A FULLY SEALED BLISTER PACK FROM BATCH 9142984 (P/N 300912). THERE WERE ALSO TWO OPENED AND EMPTY BLISTER PACKS FROM BATCH 9142988 (P/N 300912). ALL EIGHT SYRINGES WERE OBSERVED TO HAVE THE NORMAL AND EXPECTED AMOUNT OF SILICONE PER PRODUCT SPECIFICATION. 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. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
IT WAS REPORTED THAT THERE WAS EXCESS SILICONE FOUND IN THE BD SYRINGE LUER-LOK¿ TIP PISTON BEFORE USE. LOT #'S 9142984 AND 9142988 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TO MUCH SILICONE OIL IN PISTON".
IT WAS REPORTED THAT THERE WAS EXCESS SILICONE FOUND IN THE BD SYRINGE LUER-LOK¿ TIP PISTON BEFORE USE. LOT #'S 9142984 AND 9142988 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TO MUCH SILICONE OIL IN PISTON".
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THERE WAS EXCESS SILICONE FOUND IN THE BD SYRINGE LUER-LOK¿ TIP PISTON BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TOO MUCH SILICONE OIL IN PISTON."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 866508 | BD SYRINGE LUER-LOK TIP | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 9142984 | 30382903009122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |