BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
Report
- Report Number
- 2243072-2018-01652
- Event Type
- Malfunction
- Date Received
- November 27, 2018
- Date of Event
- November 1, 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
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE REPORTED MATERIAL # [MBC6010]. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.4. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BROKE APART DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. D.1. MEDICAL DEVICE BRAND NAME: BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK. D.2. COMMON DEVICE NAME: BLOOD COLLECTION SET. D.2. MEDICAL DEVICE TYPE: FMI . G.5. PMA / 510(K)#: K172763.
H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR THE HUB BREAKING DURING USAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR HUB BREAKAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE RETAIN SAMPLES WAS CONDUCTED AND ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
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.
IT WAS REPORTED THAT BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BROKE APART DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT BD¿ BCD MAXGUARD BLOOD COLLECTION DEVICE -BROKE APART DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT BD¿ BCD MAXGUARD BLOOD COLLECTION DEVICE -BROKE APART DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF EVENT: UNKNOWN.
IT WAS REPORTED THAT BD¿ BCD MAXGUARD BLOOD COLLECTION DEVICE -BROKE APART DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 948661 | BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK | BLOOD COLLECTION SET | FMI | BECTON DICKINSON | 17111501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |