MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL; MGIT; MYCOBACTERIA GROWTH INDICATOR TUBES; SYSTEM, BLOOD CULTURING

Model Number 245122

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that prior to use with bd bbl¿; mgit¿; mycobacteria growth indicator tubes error with ifu was discovered.Liquid volume of nalc/naoh should be 8ml, but it has 5ml written.

Manufacturer Narrative

Investigation: the complaint is for material number 245122, batch number unknown.The manufacturer performed the investigation.No other complaint was reported from the customer.The complaint was confirmed.Based on the investigation, the cause was misstatement with japanese ifu.This issue is affected only to japanese ifu.We are going to change misstatement with change control process.The japan team will continue to monitor the trend.

Event Description

It was reported that prior to use with bd bbl¿; mgit¿; mycobacteria growth indicator tubes error with ifu was discovered.Liquid volume of nalc/naoh should be 8ml, but it has 5ml written.

• Brand Name: BD BBL; MGIT; MYCOBACTERIA GROWTH INDICATOR TUBES
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11351756
• MDR Text Key: 242428865
• Report Number: 1119779-2021-00331
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• PMA/PMN Number: K974883
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1