MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT; SYSTEM, BLOOD CULTURING

Catalog Number 245124

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown.The date received by manufacturer has been used for this field.D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.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 while using bd bactec¿ mgit¿ 960 supplement kit there was a fungal contaminant in the panta bottle.No patient impact reported.The following information was provided by the initial reporter: "bbl mgit panta lot#3152921.Fungal contaminant in panta bottle.We reconstituted the vial and noted visibly the fungal ball in the bottle.The fungus was not in the fluid we added.

Manufacturer Narrative

H.6.Investigation summary: panta batch number 3152921 was provided by the customer.Batch history review for panta batch 3152921 was satisfactory and no quality notifications were generated during manufacturing and inspection.Qc inspection and testing were satisfactory at time of release.For this product, retention samples are maintained as individual components and no complete cartons were available for inspection.Retention samples were inspected for panta batch 3152921 (10 vials) and no media defects were observed in 10/10 of the retention samples inspected.For further investigation, two panta batch 3145445 vials were reconstituted with 3ml sterile water.The reconstituted panta with sterile water had a hazy yellow appearance.One panta vial was placed into the 20-25-degrees celsius incubator and one panta vial was placed into the 33-37-degrees celsius incubator.At the end of a 14-day incubation period no growth was observed in 2/2 incubated retention vials.One photo was received to assist with the investigation.The photo shows one reconstituted panta vial (batch 3152921) with a growth in solution no returns were received to assist with the investigation.Without the kit batch number or supplement batch number associated with this kit, this complaint cannot be confirmed.Bd will continue to trend complaints for contamination.

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 supplement kit there was a fungal contaminant in the panta bottle.No patient impact reported.The following information was provided by the initial reporter: "bbl mgit panta lot#3152921.Fungal contaminant in panta bottle.We reconstituted the vial and noted visibly the fungal ball in the bottle.The fungus was not in the fluid we added.".

• Brand Name: BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17936742
• MDR Text Key: 325837323
• Report Number: 1119779-2023-01126
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382902451242
• UDI-Public: 00382902451242
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974883
• 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: 04/02/2024

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 Catalogue Number: 245124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/14/2023
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/24/2024
• 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