FDA Adverse Event Malfunction Summary report: N

BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

MDR report key: 24947993 · Received April 21, 2026

Report

Report Number: 1024879-2026-00599
Event Type: Malfunction
Date Received: April 21, 2026
Date of Event: March 25, 2026
Report Date: March 30, 2026
Manufacturer: BECTON DICKINSON & CO (FRANKLIN LAKES)
Product Code: JKA
UDI-DI: 30382903678144
PMA / PMN Number: BK050036
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K960250. INVESTIGATION SUMMARY: BD RECEIVED 2 PHOTOS FOR INVESTIGATION, WHICH SHOW TWO SAMPLES THAT ARE ONLY HALFWAY FULL. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: DRAW VOLUME. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem · 0

IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, TWO (2) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1008467	BD VACUTAINER® SERUM BLOOD COLLECTION TUBES	TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION	JKA	BECTON DICKINSON & CO (FRANKLIN LAKES)		5105267	30382903678144

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown