FDA Adverse Event Malfunction Summary report: N

PLATE CDC ANAEROBE 5% SB 100 EA JP

MDR report key: 11609329 · Received April 2, 2021

Report

Report Number: 2243072-2021-00932
Event Type: Malfunction
Date Received: April 2, 2021
Date of Event: March 12, 2021
Report Date: March 25, 2021
Manufacturer: BECTON DICKINSON
Product Code: JSG
PMA / PMN Number: K803025
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. INVESTIGATION SUMMARY: WE CONFIRMED THE ISSUE AS A CONTAMINATION FROM ATTACHED PHOTO. THE ISSUE WAS 1CFU/PLATE BACTERIAL CONTAMINATION FROM PHOTO. DHR SAID THERE WAS NO TROUBLE DURING PRODUCTION OF PLATE#0088. THEREFORE WE COULD NOT DECIDE ROUTE CAUSE OF THIS ISSUE. NO ISSUE IN ATTRIBUTE TEST. NO ISSUE IN RETENTION SAMPLE. NO REPORT FROM OTHER CUSTOMER. WE WILL CONTINUE TO MONITOR THIS ISSUE. MAT# 252467, CDC ANA BLD, BATCH# 0344200. PRODUCTION DATE: 2020/12/23 08:35~14:25 JPT. THIS BATCH WAS (B)(4) PLATES.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE USING PLATE CDC ANAEROBE 5% SB 100 EA JP CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POLLUTION. ISSUE IS BIOLOGICAL CONTAMINATION".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
508911	PLATE CDC ANAEROBE 5% SB 100 EA JP	CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL	JSG	BECTON DICKINSON		0344200

Patients

Seq	Age	Sex	Outcome	Treatment
1