BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
Report
- Report Number
- 2243072-2019-00063
- Event Type
- Injury
- Date Received
- January 18, 2019
- Date of Event
- December 27, 2018
- Report Date
- March 29, 2019
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- PMA / PMN Number
- K172763
- Removal / Correction Number
- PAS-19-1355-FA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE REPORTED MATERIAL # [MBC6010]. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BROKE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION. MEDICAL DEVICE BRAND NAME: BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK. COMMON DEVICE NAME: BLOOD COLLECTION SET. MEDICAL DEVICE TYPE: FMI. PMA / 510(K)#: K172763.
ADDITIONAL INFORMATION: BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR MULTIPLE LOTS OF THE BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BASED ON CONFIRMED COMPLAINTS OF A BREAKAGE IN THE LUER. THIS ISSUE COULD CAUSE THE DEVICE TO LEAK OR BREAK OFF AND GET STUCK IN THE FISTULA NEEDLE PORT RENDERING THE PORT INACCESSIBLE FOR DIALYSIS. AS A RESULT, THE PATIENT WOULD NEED TO BE RE-CANNULATED WITH A NEW FISTULA NEEDLE TO OBTAIN THEIR DIALYSIS TREATMENT. PLEASE REFERENCE BD RECALL #: PAS-19-1355-FA, ASSOCIATED WITH RES82317.
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. HOWEVER, BD HAS CONDUCTED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA WHERE IMPROVEMENT OPPORTUNITIES HAVE BEEN IDENTIFIED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. BD HAD CONDUCTED A FOLLOW-UP CALL WITH THE CUSTOMER SITE TO OBTAIN CLARIFICATION ON THE EVENT DESCRIPTION NOTED IN THE RECEIVED COMPLAINT. THE CUSTOMER INDICATED THAT THEIR SITE HAS BEEN USING THE MBC6010 FOR SOME TIME NOW AND NOTICED THAT WHEN THEY SECURE THE DEVICE TO A CENTRAL VENOUS CATHETER (CVC) OR ARTERIOVENOUS FISTULA OR GRAFT (AVF/AVG) LINE CONNECTION, IT WAS GETTING STUCK OR TOO TIGHT AND THEREFORE BREAKING DURING TORQUE. WITH REGARDS TO THE SPECIFIC EVENT, THE CUSTOMER STATED THAT THE MBC6010 HAD BROKEN DURING COLLECTION OF BLOOD FROM THE AVF/AVG BLOOD LINE, WHICH IS CONNECTED THROUGH TWO LINES (EXTRACORPOREAL TUBING) FEEDING TO THE DIALYSIS INSTRUMENT AND BACK TO THE PATIENT. THE CUSTOMER CLARIFIED THAT DURING BREAKAGE OF THE DEVICE, THERE WAS NO RISK TO THE PATIENT AS ANY AIR IN THE LINE WILL BE DE-AERATED BY THE DIALYSIS INSTRUMENT BEFORE IT IS RETURNED TO THE PATIENT. THERE ARE A NUMBER OF MONITORING SYSTEMS ON THE DIALYSIS INSTRUMENT THAT WOULD PREVENT AERATED BLOOD FROM RE-ENTERING THE PATIENT. THE MBC6010 WAS ATTACHED TO THE AVF NEEDLE WHICH IS INSERTED IN AVG TO COLLECT THE BLOOD SPECIMEN. FURTHERMORE, THE CUSTOMER INDICATED THAT THE EMPLOYEE HAD SUFFERED A NEEDLE STICK FROM A CLEAN SYRINGE THEY WERE USING TO PRY OUT THE BROKEN MBC6010 LUER THAT WAS LODGED IN THE BLOOD LINE. THE NEEDLE STICK WAS NOT FROM THE MBC6010. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA WHERE IMPROVEMENT OPPORTUNITIES HAVE BEEN IDENTIFIED. AS A RESULT, THESE IMPROVEMENTS ARE BEING IMPLEMENTED TO HELP REDUCE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, A CAPA WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED IMPROVEMENT OPPORTUNITIES IN THE MANUFACTURING PROCESS AND AS A RESULT, THESE IMPROVEMENTS ARE BEING IMPLEMENTED TO HELP REDUCE FURTHER OCCURRENCES. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED IMPROVEMENT OPPORTUNITIES IN THE MANUFACTURING PROCESS AND AS A RESULT, THESE IMPROVEMENTS ARE BEING IMPLEMENTED TO HELP REDUCE FURTHER OCCURRENCES.
IT WAS REPORTED THAT THE BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK IS BREAKING CAUSING A DIRTY NEEDLE STICK.
IT WAS REPORTED THAT THE BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BROKE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT THE BLOOD COLLECTION DEVICE W/MALE LUER IS BREAKING CAUSING A DIRTY NEEDLE STICK.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT THE BLOOD COLLECTION DEVICE W/MALE LUER IS BREAKING CAUSING A DIRTY NEEDLE STICK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55516 | BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK | BLOOD COLLECTION SET | FMI | BECTON DICKINSON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |