MAUDE Adverse Event Report: BIOMERIEUX, INC BACT/ALERT® SA (PLASTIC BOTTLES)

Model Number	259789
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer in the united kingdom notified biomérieux of bact/alert® sa culture bottles leaking post sample collection.Per the customer, the bottles were leaking from the cap in the sample bag.Customer states the samples had not leaked outside the bag; therefore, no staff members were affected.The leaking bact/alert® culture bottles initiated medical intervention in the form of additional patient blood draws.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
Biomérieux was initially informed that bact/alert® sa culture bottles were leaking post sample collection.Per the customer, the bottles were leaking from the cap in the sample bag.The customer stated the samples had not leaked outside of the bag; therefore, staff members were not affected.However, new sample sets were required due to the leaking culture bottles.Additional information was received from the customer on 24aug2017.The customer reported the issue was all user error.The user attempted to take the metal cap off the bottle but encountered difficulty so stopped half way through.The customer indicated the user was looking for a new way to inoculate blood cultures.The leak was around the metal crimping where the user had tampered and caused damage,.

• Brand Name: BACT/ALERT® SA (PLASTIC BOTTLES)
• Common Device Name: BACT/ALERT® SA (PLASTIC BOTTLES)
• Manufacturer (Section D): BIOMERIEUX, INC; 100 rodolphe street; durham NC 27712
• MDR Report Key: 6802094
• Report Number: 3002769706-2017-00249
• Device Sequence Number: 13703768
• Product Code: MDB
• UDI-Device Identifier: 03573026055806
• UDI-Public: 03573026055806
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/12/2017

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: 08/18/2017
• Device Model Number: 259789
• Device Lot Number: 1047291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 09/12/2017
• 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