BD SYRINGE 10ML LL 21GA 1-1/4IN MX BUN
Report
- Report Number
- 9614033-2021-00135
- 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: ONE PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION THE FIRST PHOTOGRAPH SHOWS A MISSING NEEDLE, THE IMAGE SHOWS THAT THE METAL PART (CANNULA) IS MISSING. IN THE SECOND IMAGE, VISCOUS LIQUID IS REPORTED INSIDE THE SYRINGE, THE IMAGE IS NOT CLEAR ENOUGH TO BE ABLE TO OBSERVE THE PRESENCE OF LIQUID INSIDE THE BARREL./ FOR THE DEFECT OF VISIBLE DROPLETS, IT IS NOT POSSIBLE TO VISUALIZE OR PERFORM THE ANALYSIS OF THE REPORTED DEFECT SINCE THERE ARE NO PHYSICAL SAMPLES AND IN THE IMAGE SENT BY THE CLIENT IT IS NOT POSSIBLE TO APPRECIATE THE DEFECT. 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 FOR MISSING NEEDLE IS ASSOCIATED WITH SENSOR FAILURE AT THE INPUT OF AUTOSHIELDER PLATES. ACTION PLAN INCLUDE PLACING A PROTECTION GUARD ON THE SENSOR IS COMMITTED, TO PREVENT THE RACKS FROM MISADJUSTING THE POSITION OF THE SENSOR, THE BATCH INVOLVED IN THIS CLAIM WAS MANUFACTURED PRIOR TO THE CLOSING OF ALL THE ESTABLISHED ACTIONS. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE FOR VISIBLE DROPLETS RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/27/2022.
THE INVESTIGATION WAS UPDATED DUE TO ADDITIONAL INFORMATION: H6: INVESTIGATION SUMMARY ONE PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION THE FIRST PHOTOGRAPH SHOWS A MISSING NEEDLE, THE IMAGE SHOWS THAT THE METAL PART (CANNULA) IS MISSING. IN THE SECOND IMAGE, VISCOUS LIQUID IS REPORTED INSIDE THE SYRINGE, THE IMAGE IS NOT CLEAR ENOUGH TO BE ABLE TO OBSERVE THE PRESENCE OF LIQUID INSIDE THE BARREL. ADDITIONALLY, TWO SAMPLES RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, MISSING CANNULA AND VISIBLE SILICONE IS OBSERVED. QUANTIFICATION OF SILICONE WAS PERFORMED, RESULTS VERIFIED AMOUNT OF SILICONE WERE NOT WITHIN THE REQUIRED LIMITS. THEREFORE, EXCESS OF SILICONE IS CONFIRMED. 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. 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 ACCUMULATION OF SILICONE IN THE ASSEMBLY PROCESS. POSSIBLE ROOT CAUSE FOR MISSING NEEDLE IS ASSOCIATED WITH SENSOR FAILURE AT THE INPUT OF AUTO SHIELDER PLATES. ACTION PLAN INCLUDE PLACING A PROTECTION GUARD ON THE SENSOR IS COMMITTED, TO PREVENT THE RACKS FROM MISADJUSTING THE POSITION OF THE SENSOR, THE BATCH INVOLVED IN THIS CLAIM WAS MANUFACTURED PRIOR TO THE CLOSING OF ALL THE ESTABLISHED ACTIONS. ACTION PLAN FOR EXCESS SILICONE INCLUDES UPDATING MAINTENANCE PLAN FOR THE SILICONE INJECTION SYSTEM. H3 OTHER TEXT : SEE H10.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0290072, MEDICAL DEVICE EXPIRATION DATE: 2025-09-30, DEVICE MANUFACTURE DATE: 2020-12-14. MEDICAL DEVICE LOT #: 1131406, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30, DEVICE MANUFACTURE DATE: 2021-07-05. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE BD SYRINGE 10ML LL 21GA 1-1/4IN MX BUN, THE DEVICE EXPERIENCED LIQUID/ MOISTURE / DROPLETS WITHIN THE SYRINGE. 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. PRODUCT NOT USED ON THE PATIENT. BD 10ML SYRINGE WITH FOREIGN ELEMENT INSIDE, VISCOUS LIQUID. LOT 1131406 PR#3802004 - SYRINGE 10ML - ISSUES: FOREIGN MATTER.
IT WAS REPORTED WHEN USING THE BD SYRINGE 10ML LL 21GA 1-1/4IN MX BUN, THE DEVICE EXPERIENCED LIQUID/ MOISTURE / DROPLETS WITHIN THE SYRINGE. 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. PRODUCT NOT USED ON THE PATIENT. BD 10ML SYRINGE WITH FOREIGN ELEMENT INSIDE, VISCOUS LIQUID. LOT 1131406; PR#: (B)(4) - SYRINGE 10ML - ISSUES: FOREIGN MATTER.
IT WAS REPORTED WHEN USING THE BD SYRINGE 10ML LL 21GA 1-1/4IN MX BUN, THE DEVICE EXPERIENCED LIQUID/ MOISTURE / DROPLETS WITHIN THE SYRINGE. 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. PRODUCT NOT USED ON THE PATIENT. BD 10ML SYRINGE WITH FOREIGN ELEMENT INSIDE, VISCOUS LIQUID. LOT 1131406; PR#: (B)(4) - SYRINGE 10ML - ISSUES: FOREIGN MATTER.
IT WAS REPORTED WHEN USING THE BD SYRINGE 10ML LL 21GA 1-1/4IN MX BUN, THE DEVICE EXPERIENCED LIQUID/ MOISTURE / DROPLETS WITHIN THE SYRINGE. 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. PRODUCT NOT USED ON THE PATIENT. BD 10ML SYRINGE WITH FOREIGN ELEMENT INSIDE, VISCOUS LIQUID. LOT 1131406 (B)(4) - SYRINGE 10ML - ISSUES: FOREIGN MATTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1704646 | BD SYRINGE 10ML LL 21GA 1-1/4IN MX BUN | PISTON SYRINGE | FMF | BECTON DICKINSON DE MEXICO | SEE H.10. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |