MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS; SYSTEM, BLOOD CULTURING

Model Number	442265
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while testing with bd bactec¿ lytic/10 anaerobic/f culture vials multiple bottles were leaking.There was no report of patient or user impact.The following information was provided by the initial reporter: report of multiple bottles leaking.
Additional Manufacturer Narrative
Medical device lot #: 1098036 was reported, however, this is not a lot# manufactured for this product.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.
Additional Manufacturer Narrative
H.6.Investigation: bd was not able to perform an investigation to the retention samples since batch number is unknown (customer claim / leakage).A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.Complaint is unconfirmed.No correctives actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.H3 other text : see h.10.
Event or Problem Description
It was reported that while testing with bd bactec¿ lytic/10 anaerobic/f culture vials multiple bottles were leaking.There was no report of patient or user impact.The following information was provided by the initial reporter: report of multiple bottles leaking.

• Brand Name: BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12771772
• Report Number: 2647876-2021-00266
• Device Sequence Number: 19897048
• Product Code: MDB
• UDI-Device Identifier: 00382904422653
• UDI-Public: 00382904422653
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K954925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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
• Operator of Device: Other
• Device Model Number: 442265
• Device Catalogue Number: 442265
• Device Lot Number: 1098036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown