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

Model Number	442193
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bactec¿ plus anaerobic/f culture vials, a vial containing a patient sample broke inside the bactec device.No impact to the patient or customer was reported.The following information was provided by the initial reporter: "bottle contained patient sample fluid was contained within the instrument.Reviewed, pending additional information it was reported by the customer that there was a broken bottle in drawer a.Customer problem: customer is reporting a broken bottle in drawer a the bottle broke as the attempted to close drawer.The cleaned up spill and no one was hurt.".
Additional Manufacturer Narrative
Medical device expiration date: unknown a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary: bd was not able to perform an investigation to the retention samples since batch number is unknown.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.Customer letter # shq-170 should be provided.Complaint is unconfirmed.No correctives actions were required.
Event or Problem Description
It was reported that while using bd bactec¿ plus anaerobic/f culture vials, a vial containing a patient sample broke inside the bactec device.No impact to the patient or customer was reported.The following information was provided by the initial reporter: "bottle contained patient sample fluid was contained within the instrument.Reviewed, pending additional information it was reported by the customer that there was a broken bottle in drawer a.Customer problem: customer is reporting a broken bottle in drawer a the bottle broke as the attempted to close drawer.The cleaned up spill and no one was hurt.".

• Brand Name: BD BACTEC¿ PLUS 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13237579
• Report Number: 2647876-2021-00387
• Device Sequence Number: 17325236
• Product Code: MDB
• UDI-Device Identifier: 00382904421939
• UDI-Public: (01)00382904421939
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K921133
• 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): 01/24/2022

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: 442193
• Device Catalogue Number: 442193
• Device Lot Number: UNKNOWN
• 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: 12/17/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 01/27/2022
• 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