MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD GASPAK EZ ANAEROBE CONTAINER SYSTEM; DEVICE, GAS GENERATING

Model Number 260678

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd gaspak¿ ez anaerobe container system a false positive result was obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device expiration date: 2021-11-01 h4: device manufacture date: 2020-06-25 h6: investigation summary the investigation required to perform anaerobic reduction, microbiological performance, gas concentration test, visual inspection.Retention samples performed as expected.No discrepancies observed during the visual inspection.No product trend identified for catalog 260678.No corrective action is required based on information evaluated.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.H3 other text : see h10.

Event Description

It was reported that while using bd gaspak¿ ez anaerobe container system a false positive result was obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: BD GASPAK EZ ANAEROBE CONTAINER SYSTEM
• Type of Device: DEVICE, GAS GENERATING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11426168
• MDR Text Key: 259582380
• Report Number: 3008352382-2021-00060
• Device Sequence Number: 1
• Product Code: KZJ
• UDI-Device Identifier: 30382902606780
• UDI-Public: 30382902606780
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2021
• Device Model Number: 260678
• Device Catalogue Number: 260678
• Device Lot Number: 0177957
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1