FDA Adverse Event Malfunction Summary report: N

BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

MDR report key: 18291353 · Received December 8, 2023

Report

Report Number: 1024879-2023-00882
Event Type: Malfunction
Date Received: December 8, 2023
Date of Event: November 14, 2023
Report Date: December 15, 2023
Manufacturer: BECTON, DICKINSON & CO., (BD)
Product Code: JKA
UDI-DI: 50382903673426
PMA / PMN Number: K030573
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1024879-2023-00882 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

Additional Manufacturer Narrative · 0

D.1 MEDICAL DEVICE TYPE: FPA. THERE WERE MULTIPLE 510K : G.5 PMA / 510(K)#: K220212. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS MISSING COMPONENT OF PRODUCT. NO PATIENT IMPACT.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS MISSING COMPONENT OF PRODUCT. NO PATIENT IMPACT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
212182	BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET	BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET	JKA	BECTON, DICKINSON & CO., (BD)		3061827	50382903673426

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown