BD SWAB BBL SGL F/F
Received Sep 20, 2021 · Event occurred Aug 24, 2021
Report 1119779-2021-01547 · MDR key 12502877
Device
Generic name
System, Transport, Anaerobic
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
212550
Lot number
203203800
Product problems
- Missing Information
- Missing Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 1119779-2021-01547 WAS SENT IN ERROR. ACCORDING TO PICTURE RECEIVED FROM CUSTOMER, THE LABEL IS NOT MISSING THE INSERT WAS DETACHED, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT 50 BD SWAB BBL SGL F/F EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE DOCUMENT WHICH WAS SUPPOSED TO BE AFFIXED TO THE PACKAGE WAS DETACHED AND FOUND SEPARATELY.
Additional Manufacturer Narrative
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
IT WAS REPORTED THAT 50 BD SWAB BBL SGL F/F EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE DOCUMENT WHICH WAS SUPPOSED TO BE AFFIXED TO THE PACKAGE WAS DETACHED AND FOUND SEPARATELY.