SYRINGE 50ML LL TIP 1ML
Report
- Report Number
- 1911916-2024-00891
- Event Type
- Malfunction
- Date Received
- December 11, 2024
- Date of Event
- September 26, 2024
- Report Date
- January 18, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- UDI-DI
- 30382903096535
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4) FOLLOW UP. IT WAS REPORTED A SMUDGE WAS FOUND IN THE 50ML SYRINGE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW DARK COLORED PARTICLES THAT ARE NOT UNIFORM IN SHAPE OR SIZE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 3299559. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
(B)(4) FOLLOW UP. IT WAS REPORTED A SMUDGE WAS FOUND IN THE 50ML SYRINGE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. TWO PHOTOS SHOW DARK COLORED PARTICLES THAT ARE NOT UNIFORM IN SHAPE OR SIZE. ONE PHOTO SHOWS A SYRINGE WITH A DARK COLORED SPECK ON AT THE BOTTOM. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 3299559. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
(B)(4) FOLLOW UP: IT WAS REPORTED A SMUDGE WAS FOUND IN THE 50ML SYRINGE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW DARK COLORED PARTICLES THAT ARE NOT UNIFORM IN SHAPE OR SIZE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
NO ADDITIONAL INFORMATION RECEIVED.
DESCRIPTION/EVENT DETAILS: CATALOGUE NUMBER: 309653. A PARTICLE/SMUDGE WAS FOUND IN THE 50 ML SYRINGE DURING BUBBLE REMOVAL ONCE THE PLUNGER WAS RETRACTED ABOUT HALFWAY. THERE WAS ABOUT 3-4ML OF CELL SUSPENSION IN THE SYRINGE, IN CONTACT WITH THE SMUDGE/PARTICLE. DURING ISOLATION, THE PARTICLE LOOKED MORE LIKE MAGNETIC DUST, NOT POSSIBLE TO TAKE OUT AS ONE PIECE NOR WITH PINCER (WENT THROUGH THE PARTICLE). MULTIPLE DOTS WERE SCRAPPED TO THE FILTER FOR IR ANALYSIS, WHICH INDICATED THAT IT CONSISTS OF A MIXTURE OF MULTIPLE COMPONENTS (A SILICATE, A SILICONE, AN INORGANIC SULPHATE AND MOST LIKELY AT LEAST TWO DIFFERENT COMPONENTS WITH SATURATED ALIPHATIC CHAINS). ADDITIONAL EDX ANALYSIS INDICATED THAT THE RESIDUE IS COMPOSED OF C, O, SI, S, BA AND TRACES OF ZN (AND POSSIBLY TRACES OF NA AND/OR SOME AL AS WELL). BASED ON THE ANALYSES THAT WERE PERFORMED, THE RESIDUE COULD BE IDENTIFIED AS A MIXTURE OF COMPONENTS INCLUDING (BUT NOT LIMITED TO) A SILICATE, A SILICONE, BARIUM SULPHATE AND UNSPECIFIED ORGANIC COMPOUNDS WITH SATURATED ALIPHATIC CHAINS. WAS AFFECTED PRODUCT USED ON A PATIENT? NO.
NO ADDITIONAL INFORMATION RECEIVED.
NO ADDITIONAL INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2494089 | SYRINGE 50ML LL TIP 1ML | SYRINGE, PISTON | FMF | BECTON DICKINSON | 3299559 | 30382903096535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |