FDA Adverse Event Malfunction Summary report: N

BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

MDR report key: 24971286 · Received April 23, 2026

Report

Report Number: 1024879-2026-00618
Event Type: Malfunction
Date Received: April 23, 2026
Date of Event: March 16, 2026
Report Date: March 28, 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 HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: DAMAGED. 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, ONE TUBE WAS CRACKED RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
382118	BD VACUTAINER® SERUM BLOOD COLLECTION TUBES	TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION	JKA	BECTON DICKINSON & CO (FRANKLIN LAKES)		5202179	30382903678144

Patients

Seq	Age	Sex	Outcome	Treatment
1