FDA Adverse Event Malfunction Summary report: N

BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES

MDR report key: 7583169 · Received June 8, 2018

Report

Report Number: 2243072-2018-01270
Event Type: Malfunction
Date Received: June 8, 2018
Date of Event: November 17, 2016
Report Date: May 17, 2018
Manufacturer: BECTON DICKINSON
Product Code: JKA
UDI-DI: 50382903679251
PMA / PMN Number: K901449
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MULTIPLE PMA / 510(K) NUMBERS: THERE WERE MULTIPLE PMA / 510(K) NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL PMA / 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K945952. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES WERE UNDERDRAWING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
426513	BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES	BLOOD SPECIMEN COLLECTION DEVICE	JKA	BECTON DICKINSON		UNKNOWN	50382903679251

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other