BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
Report
- Report Number
- 3003152976-2022-00426
- Event Type
- Malfunction
- Date Received
- September 20, 2022
- Date of Event
- August 24, 2022
- Report Date
- November 21, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- UDI-DI
- 00382903008650
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT: 2203085, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THIS INCIDENT IS DUE TO PERSONNEL NOT FOLLOWING THE PROPER GOWNING PROCEDURE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 07-NOV-2022 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A HAIR WAS OBSERVED, VERIFYING THE REPORTED ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2203085, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT IS DUE TO PERSONNEL NOT FOLLOWING THE PROPER GOWNING PROCEDURE.
IT WAS REPORTED THAT A HAIR WAS FOUND IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHILE PREPARING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "PRESENCE OF A HAIR IN A 50ML BD SYRINGE FOUND DURING THE PREPARATION OF AN EXPENSIVE PRODUCT FOR ADMINISTRATION. PREPARATION RENDERED UNFIT FOR ADMINISTRATION".
IT WAS REPORTED THAT A HAIR WAS FOUND IN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHILE PREPARING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "PRESENCE OF A HAIR IN A 50ML BD SYRINGE FOUND DURING THE PREPARATION OF AN EXPENSIVE PRODUCT FOR ADMINISTRATION. PREPARATION RENDERED UNFIT FOR ADMINISTRATION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2662237 | BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2203085 | 00382903008650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |