BD LUER-LOK¿ SYRINGE
Report
- Report Number
- 1213809-2022-01218
- Event Type
- Malfunction
- Date Received
- December 12, 2022
- Date of Event
- November 11, 2022
- Report Date
- January 23, 2023
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 00382903096572
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2063145. D4: MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027. H4: DEVICE MANUFACTURE DATE: 04-MAR-2022. D4: MEDICAL DEVICE LOT #: 2209582. D4: MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2027. H4: DEVICE MANUFACTURE DATE: 28-JUL-2022. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGES ARE CRACKED. TO AID IN THE INVESTIGATION, FOUR 3ML SYRINGES AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THREE SYRINGES WERE LOOSE IN A BAG AND ONE SYRINGE WITH SEALED IN A PACKAGING BLISTER FROM LOT 2063145. A VISUAL INSPECTION WAS PERFORMED AND THE SAMPLE INSIDE THE PACKAGING BLISTER HAS NO DEFECTS. ONE OF THE LOOSE SAMPLES HAD TWO VERTICAL CRACKS; ONE INSIDE THE PRINT AREA ON THE NUMERALS EXTENDING HALFWAY DOWN THE BARREL, AND ONE ON THE OPPOSITE SIDE OF THE PRINT AREA THAT WAS SLIGHTLY SHORTER IN LENGTH. THE OTHER TWO LOOSE SAMPLES EACH HAD A VERTICAL CRACK OUTSIDE THE PRINT AREA APPROXIMATELY ONE QUARTER TO ONE HALF THE LENGTH OF THE BARREL. THE THREE PHOTOS EACH DISPLAYED A SYRINGE OR SYRINGES BEING HELD THAT HAD VISIBLE LENGTHWISE CRACKS RUNNING UP THE SIDE OF THE BARREL BOTH INSIDE AND OUTSIDE THE PRINT AREA. THE OBSERVED DAMAGE WAS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS LIKELY A MACHINE JAM OR IMPROPER TRANSFER BETWEEN ASSEMBLY DIALS LED TO THE COMPLAINT DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309657, LOT NUMBERS 2181851, 2063145, AND 2209582. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH NUMBERS 2181851, 2063145, AND 2209582 WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT.
THE INVESTIGATION SUMMARY HAS BEEN UPDATED WITH ADDITIONAL INFORMATION, IMDRF CODING WAS NOT AFFECTED. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE ARE CRACKS IN SYRINGES. TO AID IN THE INVESTIGATION, THREE PHOTOS AND EIGHT SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. FIVE WERE LOOSE IN A BAG, ONE WAS SEALED IN A PACKAGING BLISTER WITH LOT 2063145, AND TWO SAMPLES WERE SEALED IN BLISTER PACKAGES FROM LOT 2181851. THE SAMPLES IN THE SEALED PACKAGING BLISTERS HAVE NO VISIBLE DEFECTS AND ARE ACCEPTABLE PER PRODUCT SPECIFICATION. ONE OF THE LOOSE SAMPLES WAS OBSERVED TO HAVE TWO VERTICAL CRACKS; ONE INSIDE THE PRINT AREA ON THE NUMERALS EXTENDING HALFWAY DOWN THE BARREL, AND ONE ON THE OPPOSITE SIDE OUTSIDE OF THE PRINT AREA THAT WAS SLIGHTLY SHORTER. ANOTHER TWO LOOSE SAMPLES WERE EACH OBSERVED TO HAVE A VERTICAL CRACK OUTSIDE OF THE PRINT AREA APPROXIMATELY ONE QUARTER TO ONE HALF THE LENGTH OF THE BARREL. THE REMAINING TWO SAMPLES WERE OBSERVED TO HAVE A VERTICAL CRACK IN THE PRINT AREA, ONE WAS BETWEEN THE 0ML LINE AND THE 1.5ML LINE, AND THE OTHER BETWEEN THE 0.5ML AND 2ML LINE. THE PHOTOS RECEIVED ALL SHOWED VERTICAL CRACKS ON ONE OR MORE SYRINGES WHICH MATCHED THE CONDITION FROM THE RECEIVED SAMPLES. THE OBSERVED DAMAGE ON THE SAMPLES IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THIS DEFECT CAN OCCUR IF THERE WAS A MACHINE JAM OR IMPROPER TRANSFER BETWEEN ASSEMBLY DIALS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309657, LOT NUMBERS 2181851, 2063145 AND 2209582. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH NUMBERS 2181851, 2063145 AND 2209582 WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THIS DEFECT APPEARS TO BE OCCURRING AT OR BELOW ITS EXPECTED FREQUENCY. BATCHES 2181851, 2063145 AND 2209582 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE LOST 300 CC¿S OF BOTOX DUE TO CRACKS IN THE SYRINGES WHILE DR. WAS ADMINISTERING THE MEDICATION. REPORTS THAT THE SYRINGES ARE CRACKED AND BOTOX WAS LEAKING OUT OF THEM.
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE LOST 300 CC¿S OF BOTOX DUE TO CRACKS IN THE SYRINGES WHILE DR. WAS ADMINISTERING THE MEDICATION. REPORTS THAT THE SYRINGES ARE CRACKED AND BOTOX WAS LEAKING OUT OF THEM.
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE LOST 300 CC¿S OF BOTOX DUE TO CRACKS IN THE SYRINGES WHILE DR. WAS ADMINISTERING THE MEDICATION. REPORTS THAT THE SYRINGES ARE CRACKED AND BOTOX WAS LEAKING OUT OF THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2130678 | BD LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | SEE H10 | 00382903096572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |