120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP

MDR report key: 7074952 · Received December 1, 2017

Report

Report Number: 1917413-2017-00203
Event Type: Malfunction
Date Received: December 1, 2017
Date of Event: April 4, 2016
Report Date: January 24, 2018
Manufacturer: BECTON, DICKINSON & CO.
Product Code: KDT
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS K790366. IT IS CORRECTED TO READ EXEMPT.

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD OF 4/4/2017. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER OR MOLD ON URINE CUPS WITH THE INCIDENT LOT WAS NOT OBSERVED. 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. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A MOLD APPEARANCE ON SEVERAL 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUPS. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
853768	120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP	URINE COLLECTION CUP	KDT	BECTON, DICKINSON & CO.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other