BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
Report
- Report Number
- 2243072-2018-01937
- Event Type
- Malfunction
- Date Received
- January 8, 2019
- Date of Event
- December 19, 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
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK IS BREAKING AT THE MALE CONNECTOR WHEN BEING ATTACHED TO A SYRINGE AND FAILING TO CONTAIN BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. D.1. MEDICAL DEVICE BRAND NAME: BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK, D.2. MEDICAL DEVICE TYPE: FMI, D.2. COMMON DEVICE NAME: BLOOD COLLECTION SET, G.5. 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 RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE CUSTOMER SAMPLES, ALONG WITH RETENTION SAMPLES OF THE INCIDENT LOT (FROM BD INVENTORY), WERE EVALUATED AND MECHANICALLY TESTED; UPON COMPLETION, ALL RESULTS MET RELEASE SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION/TESTING OF THE CUSTOMER AND RETAIN SAMPLES, ALL RESULTS MET RELEASE SPECIFICATIONS. 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: 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. 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 BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK IS BREAKING AT THE MALE CONNECTOR WHEN BEING ATTACHED TO A SYRINGE AND FAILING TO CONTAIN BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUER IS BREAKING AT THE MALE CONNECTOR WHEN BEING ATTACHED TO A SYRINGE AND FAILING TO CONTAIN BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUER IS BREAKING AT THE MALE CONNECTOR WHEN BEING ATTACHED TO A SYRINGE AND FAILING TO CONTAIN BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUER IS BREAKING AT THE MALE CONNECTOR WHEN BEING ATTACHED TO A SYRINGE AND FAILING TO CONTAIN BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21557 | BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK | BLOOD COLLECTION SET | FMI | BECTON DICKINSON | 18050501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |