BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE

MDR report key: 7080443 · Received December 4, 2017

Report

Report Number: 2243072-2017-00339
Event Type: Malfunction
Date Received: December 4, 2017
Date of Event: November 26, 2015
Report Date: January 24, 2018
Manufacturer: BD CARIBE LTD.
Product Code: JKA
UDI-DI: 00382903649020
PMA / PMN Number: K991088
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EI
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS N/A. IT IS CORRECTED TO READ K991088.

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). BD RECEIVED 18 SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 50 RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE TUBE WAS INSERTED IN THE LLAD, BLOOD STARTED TO LEAK FROM THE NEEDLE INSIDE THE LLAD DOWN THE OUTSIDE OF THE TUBE. THIS IS RELATED TO A SIDE SLEEVE PIERCED DEFECT, WHICH IS RELATED TO SLEEVE LEAK FAILURE. THERE WAS NO REPORT OF BLOOD EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
859723	BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE	BLOOD COLLECTION ADAPTER	JKA	BD CARIBE LTD.		5016809	00382903649020

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other