BD LUER-LOK
Report
- Report Number
- 1213809-2024-00468
- Event Type
- Malfunction
- Date Received
- July 16, 2024
- Date of Event
- April 29, 2024
- Report Date
- October 2, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096283
- PMA / PMN Number
- K941562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
THREE PHOTOS OF A 1ML LUER-LOK SYRINGE WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE PHOTOS FROM BATCH: 0160885 REGARDING ITEM: 309628. ALL THREE IMAGES SHOW A LOOSE SYRINGE WITH AN UNKNOWN CLEAR TIP ATTACHED; FURTHERMORE, IT APPEARS THAT THE TIP IS BROKEN. TWO OF THE PHOTOS ARE A CLOSE-UP IMAGE OF THE BARREL TIP AND THE BARREL IS NOT BROKEN IN ANY MANNER IN EITHER OF THE PHOTOS. ONE IMAGE SHOWS THE LOOSE SYRINGE LAYING NEXT TO A VIAL, A BLUE SHIELD, AND AN "EYELEA" BOX CARTON. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. A MOLDING ENGINEER WAS CONSULTED AND CONFIRMED THAT THE BROKEN PIECE OF MATERIAL AT THE END OF THE BARREL TIP IS NOT FROM THE MANUFACTURING PROCESS. THE BROKEN PIECE OBSERVED IS NOT INCLUDED IN THE PACKAGE OF THIS MATERIAL AND BATCH FROM THE CANAAN MANUFACTURING PLANT. THE DEFECT OBSERVED COULD NOT BE CONFIRMED TO HAVE ORIGINATED AT THE MANUFACTURING PLANT, THEREFORE CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER: 0160885 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
MATERIAL# 309628. BATCH# 0160885. IT WAS REPORTED THAT THE BD LUER-LOK LUER WAS CRACKED/DAMAGED/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM. RCC RECEIVED A COMPLAINT VIA EMAIL. ON 30-APR-2024, THE REPORTER CONTACTED MEDICAL INFORMATION VIA PHONE TO REQUEST REPLACEMENT OF 1 EYLEA HD UNIT(S). THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT. PER THE REPORTER, ON 29-APR-2024, WHEN THE HCP WENT TO ATTACH THE NEEDLE TO THE SYRINGE, THE SYRINGE BROKE. IT BROKE AT THE LUER LOCK END AND IT GOT STUCK TO THE NEEDLE. THE HCP STATED SHE IS UNABLE TO "GET IT OFF". THE CALL WAS DISCONNECTED. MEDICAL INFORMATION MADE AN OUTBOUND CALL TO THE REPORTER ON 30-APR-2024, A VOICEMAIL COULD NOT BE LEFT, SINCE THE REPORTER'S VOICEMAIL WAS FULL. MEDICAL INFORMATION EMAILED THE REPORTER, REQUESTING HER TO CONTACT MEDICAL INFORMATION. MEDICAL INFORMATION WAS UNABLE TO GATHER ANSWERS FOR THE "VIAL BROKEN OR DAMAGED SYRINGES/NEEDLES" QUESTIONNAIRE. THE REPORTER HAD THE 1 EYLEA HD UNIT AVAILABLE FOR RETURN AND WAS INSTRUCTED TO RETAIN THE PRODUCT FOR RETRIEVAL. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. VERSION 2 (BMONDONEDO). ON 30APR2024, THE REPORTER CALLED MEDICAL INFORMATION BACK TO PROVIDE REPSPONSES TO THE "VIAL BROKEN OR DAMAGED SYRINGES/NEEDLES" QUESTIONNAIRE. PLEASE SEE THE RESPONSES BELOW. ARE YOU COMPLETING THIS FORM? BD LOT CATALOG AND LOT NUMBERS OF THE 1ML PLASTIC SYRINGE CATALOG NUMBER 309628/ BD LOT NUMBER 2299220G.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2508456 | BD LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 0160885 | 30382903096283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |