BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Report
- Report Number
- 3002682307-2023-00008
- Event Type
- Malfunction
- Date Received
- January 28, 2023
- Date of Event
- January 11, 2023
- Report Date
- March 10, 2023
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AFTER FURTHER REVIEW, THE PRODUCT NUMBER PROVIDED BY THE CUSTOMER DID NOT CORRESPOND WITH THE EVENT DESCRIPTION. AS A RESULT, THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 10 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES' PLUNGER RODS HAD OILY FOREIGN MATTER ON THEM. D.1. MEDICAL DEVICE BRAND NAME: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE D.2. MEDICAL DEVICE CATALOG#: 301229 D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A. (SAN AGUSTIN, SPAIN) D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: BECTON DICKINSON, S.A. (SAN AGUSTIN, SPAIN) H.4. DEVICE MANUFACTURE DATE: 20-JUN-2022
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION HAVE BEEN PROVIDED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2206110, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2206110 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO FOREIGN MATTER OR OTHER LIQUID WAS OBSERVED INSIDE ANY OF THE SYRINGES. IT IS POSSIBLE THE LIQUID THAT WAS DESCRIBED TO BE OBSERVED IN THE SYRINGE WAS SILICONE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR LOT 2206110 AND FOUND TO BE WITHIN SPECIFICATION. SILICONE CAN BE VISIBLE DUE TO ISSUES RELATED TO POOR DISTRIBUTION INSIDE THE BARREL. AS NO DEFECT WAS OBSERVED IN THE RETAINED SAMPLES AND DEVICE RECORDS DO NOT INDICATE ANY ISSUES OCCURRED DURING MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.
IT WAS REPORTED THAT 10 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES' PLUNGER RODS HAD OILY FOREIGN MATTER ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "PARENTS OF THE PATIENT USED 30ML SYRINGES OF BD TO ADMINISTER SCIG. THEY NOTICED THAT, WHEN PULLED UP, THERE WAS A SMALL 'OIL' LIKE SUBSTANCE IN THE SYRINGE. THEY PULLED THE PLUNGER OUT OF THE SYRINGE AND FELT AN OILY SUBSTANCE AT THE END OF THE PLUNGER, BLACK , RUBBER PART. I MYSELF DROVE TO THE PATIENT AND ALSO REMOVED THE PLUNGER AND IT FELT LIKE THERE IS SOME MOISTURE/OIL (HARD TO TELL BECAUSE OF THE AMOUNT) PRESENT IN THE SYRINGE."
IT WAS REPORTED THAT 10 BD EMERALD¿ SYRINGES' PLUNGER RODS HAD OILY FOREIGN MATTER ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "PARENTS OF THE PATIENT USED 30ML SYRINGES OF BD TO ADMINISTER SCIG. THEY NOTICED THAT, WHEN PULLED UP, THERE WAS A SMALL 'OIL' LIKE SUBSTANCE IN THE SYRINGE. THEY PULLED THE PLUNGER OUT OF THE SYRINGE AND FELT AN OILY SUBSTANCE AT THE END OF THE PLUNGER, BLACK , RUBBER PART. I MYSELF DROVE TO THE PATIENT AND ALSO REMOVED THE PLUNGER AND IT FELT LIKE THERE IS SOME MOISTURE/OIL (HARD TO TELL BECAUSE OF THE AMOUNT) PRESENT IN THE SYRINGE."
IT WAS REPORTED THAT 10 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES' PLUNGER RODS HAD OILY FOREIGN MATTER ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "PARENTS OF THE PATIENT USED 30ML SYRINGES OF BD TO ADMINISTER SCIG. THEY NOTICED THAT, WHEN PULLED UP, THERE WAS A SMALL 'OIL' LIKE SUBSTANCE IN THE SYRINGE. THEY PULLED THE PLUNGER OUT OF THE SYRINGE AND FELT AN OILY SUBSTANCE AT THE END OF THE PLUNGER, BLACK , RUBBER PART. I MYSELF DROVE TO THE PATIENT AND ALSO REMOVED THE PLUNGER AND IT FELT LIKE THERE IS SOME MOISTURE/OIL (HARD TO TELL BECAUSE OF THE AMOUNT) PRESENT IN THE SYRINGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401348 | BD PLASTIPAK¿ LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2206110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |