MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® SA CULTURE BOTTLE

Catalog Number	259789
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer in (b)(6) notified biomérieux of deformed bact/alert® sa culture bottle.The customer reported that one of the deformed bottles was identified after inoculation.The deformation is on the side of the bottle and a crack was also observed.The customer reported having to collect blood from the patient again.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: the investigation examined the manufacturing directions, including the quality control release testing and all results were within specification.Quality assurance subsequently released the finished goods.The root cause for the collapsed bottle was not determined.At this time, we consider this a manufacturing variance and will continue to monitor this issue.The instructions for use state prior to use, visually inspect all bact/alert® bottles.Bottles exhibiting evidence of damage or deterioration should be discarded.

• Brand Name: BACT/ALERT® SA CULTURE BOTTLE
• Common Device Name: BACT/ALERT® SA CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7139416
• Report Number: 3002769706-2017-00409
• Device Sequence Number: 16416873
• Product Code: MDB
• UDI-Device Identifier: 03573026055806
• UDI-Public: 03573026055806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2018
• Device Catalogue Number: 259789
• Device Lot Number: 1048669
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention