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

Model Number 442020

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/01/2022

Event Type  malfunction  

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¿ peds plus¿/ f culture vials (plastic) growth of bgp was observed.The following information was provided by the initial provided by the initial reporter: in blood culture samples, the growth of bgp - gran positive bacillus, a characteristic contamination microorganism, was observed.

Event Description

It was reported that bd bactec¿ peds plus¿/ f culture vials (plastic) growth of bgp was observed.The following information was provided by the initial provided by the initial reporter: in blood culture samples, the growth of bgp - gran positive bacillus, a characteristic contamination microorganism, was observed.

Manufacturer Narrative

H.6 investigation summary: catalog 442020.Batch no.2041427.Customer reported a contamination issue.Eight photos of carton case and bottles were received.Upon further evaluation it was noticed that complaint received was from a product already expired.Investigation cannot be conducted to the retention samples since the product is already expired.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.The batch history record was not reviewed as the lot is expired, 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.The specimen must be collected using sterile techniques to reduce the chance of contamination.Do not use culture vials past their expiration date.Users are cautioned in the package insert under limitation of the procedure: ¿a gram-stained smear from culture medium may contain small number of non-viable organisms derived from media constituents, staining reagents, immersion oil, glass slide and specimens used for inoculation.There are many factors that can influence the false positive rate, including blood volume, blood cell counts, environmental factors, and media lot to lot variations.Complaint is unconfirmed.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.

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ 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: 16044729
• MDR Text Key: 308309667
• Report Number: 2647876-2022-00242
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K151866
• 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: 01/24/2023

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: 442020
• Device Catalogue Number: 442020
• Device Lot Number: 204142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1