BD SYRINGE 20ML LL SYRINGE ONLY MX BUN
Report
- Report Number
- 9614033-2021-00134
- Event Type
- Malfunction
- Date Received
- November 12, 2021
- Date of Event
- October 4, 2021
- Report Date
- July 13, 2022
- Manufacturer
- BECTON DICKINSON DE MEXICO
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION A 20 ML SYRINGE IS SHOWN, THE REPORTED BATCH 1071414 IS CONFIRMED IN THE BLISTER. IT IS NOT POSSIBLE TO APPRECIATE THE PIVOT IN DETAIL, SO IT IS NOT POSSIBLE TO DETERMINE IF THERE IS DAMAGE TO THE LUER LOCK CONNECTION. 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. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE FOR SYRINGE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE INVESTIGATION WAS UPDATED DUE TO ADDITIONAL INFORMATION: H6: INVESTIGATION SUMMARY PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION A 20 ML SYRINGE IS SHOWN, THE REPORTED BATCH 1071414 IS CONFIRMED IN THE IMAGE. ADDITIONALLY, SAMPLE RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, LUER TIP APPEARS DEFORMED AND DAMAGED. 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. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE MOLDING PROCESS. THE LUER GETS STUCK IN THE NOZZLES GENERATING DAMAGE. ACTION WAS TAKEN TO REVIEW OF THE CORRECT OPERATION OF THE SENSOR IN THE MARKING MACHINE, REVIEW LUER FOR THIS MOLD TO ENSURE THERE IS NO DAMAGE, INCLUDE REVISION IN THE ANNUAL PREVENTIVE MAINTENANCE PROGRAM, REVIEW OF LUER TIP IN THE 20ML LINES, AND MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL?: YES. D9: RETURNED TO MANUFACTURER ON: 1/27/2022.
IT WAS REPORTED WHEN USING THE BD SYRINGE 20ML LL SYRINGE ONLY MX BUN, THE DEVICE EXPERIENCED THE TIP OF THE LUER OR THE SYRINGE CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE REPORT OF VARIOUS SITUATIONS OF QUALITY AND SAFETY OF BD BRAND PLASTIC SYRINGES OF VARIOUS VOLUMES IS CARRIED OUT. THE SITUATIONS ARE MANUFACTURING DEFECTS AND THE PRESENCE OF EXTRANEOUS ELEMENTS. FOR THE 20ML SYRINGE IT IS REPORTED: "BD BRAND 20ML SYRINGE WITH DEFAULT, DEFORMATION IN THE LUER-LOCK SYSTEM. LOT 1071414."
IT WAS REPORTED WHEN USING THE BD SYRINGE 20ML LL SYRINGE ONLY MX BUN, THE DEVICE EXPERIENCED THE TIP OF THE LUER OR THE SYRINGE CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE REPORT OF VARIOUS SITUATIONS OF QUALITY AND SAFETY OF BD BRAND PLASTIC SYRINGES OF VARIOUS VOLUMES IS CARRIED OUT. THE SITUATIONS ARE MANUFACTURING DEFECTS AND THE PRESENCE OF EXTRANEOUS ELEMENTS. FOR THE 20ML SYRINGE IT IS REPORTED: "BD BRAND 20ML SYRINGE WITH DEFAULT, DEFORMATION IN THE LUER-LOCK SYSTEM. LOT 1071414."
IT WAS REPORTED WHEN USING THE BD SYRINGE 20ML LL SYRINGE ONLY MX BUN, THE DEVICE EXPERIENCED THE TIP OF THE LUER OR THE SYRINGE CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE REPORT OF VARIOUS SITUATIONS OF QUALITY AND SAFETY OF BD BRAND PLASTIC SYRINGES OF VARIOUS VOLUMES IS CARRIED OUT. THE SITUATIONS ARE MANUFACTURING DEFECTS AND THE PRESENCE OF EXTRANEOUS ELEMENTS. FOR THE 20ML SYRINGE IT IS REPORTED: "BD BRAND 20ML SYRINGE WITH DEFAULT, DEFORMATION IN THE LUER-LOCK SYSTEM. LOT 1071414."
IT WAS REPORTED WHEN USING THE BD SYRINGE 20ML LL SYRINGE ONLY MX BUN, THE DEVICE EXPERIENCED THE TIP OF THE LUER OR THE SYRINGE CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE REPORT OF VARIOUS SITUATIONS OF QUALITY AND SAFETY OF BD BRAND PLASTIC SYRINGES OF VARIOUS VOLUMES IS CARRIED OUT. THE SITUATIONS ARE MANUFACTURING DEFECTS AND THE PRESENCE OF EXTRANEOUS ELEMENTS. FOR THE 20ML SYRINGE IT IS REPORTED: "BD BRAND 20ML SYRINGE WITH DEFAULT, DEFORMATION IN THE LUER-LOCK SYSTEM. LOT 1071414."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1702310 | BD SYRINGE 20ML LL SYRINGE ONLY MX BUN | PISTON SYRINGE | FMF | BECTON DICKINSON DE MEXICO | 1071414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |