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

Model Number 442023

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) had the label half peeled off.No patient impact reported.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s report, the label is half peeled off.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) had the label half peeled off.No patient impact reported.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s report, the label is half peeled off.

Manufacturer Narrative

H.6 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.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.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: 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: 15580684
• MDR Text Key: 307102178
• Report Number: 2647876-2022-00216
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1