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

Model Number 442021

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/04/2022

Event Type  malfunction  

Event Description

It was reported by the customer that bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) had no label or missing label information (all packaging levels).There was one occurrence in this event with no patient impact.The following information was provided by the customer: "the nurse followed the doctor's instructions to carry out blood culture + drug sensitivity blood draw for the patient, found that the bottle label part of the anaerobic microbial culture bottle was missing, the nurse believed that the reagent bottle itself was not damaged, and within the validity period, the product was used to continue to complete the blood collection, after the specimen was sent for examination, because the label was missing, the laboratory department could not detect, the consumables were discarded, that is, the material supply management department was reported to the material supply management department, and the material supply management department was investigated, and the procurement office notified the supplier to the department to view and process.".

Manufacturer Narrative

Initial reporter phone number: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: satisfactory results were obtained from retention samples when visually inspected for reported defect (no vial label).Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history record review.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.No corrective 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 investigational process.

Event Description

It was reported by the customer that bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) had no label or missing label information (all packaging levels).There was one occurrence in this event with no patient impact.The following information was provided by the customer: "the nurse followed the doctor's instructions to carry out blood culture + drug sensitivity blood draw for the patient, found that the bottle label part of the anaerobic microbial culture bottle was missing, the nurse believed that the reagent bottle itself was not damaged, and within the validity period, the product was used to continue to complete the blood collection, after the specimen was sent for examination, because the label was missing, the laboratory department could not detect, the consumables were discarded, that is, the material supply management department was reported to the material supply management department, and the material supply management department was investigated, and the procurement office notified the supplier to the department to view and process.".

• Brand Name: BD BACTEC¿ LYTIC/10 ANAEROBIC/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: 15456960
• MDR Text Key: 306322393
• Report Number: 3008352382-2022-00004
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: (01)00382904420215
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 2041433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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