MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS

Catalog Number 442194

Device Problem Microbial Contamination of Device (2303)

Patient Problem Death (1802)

Event Date 04/10/2018

Event Type  Death  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Investigation: bd diagnostic systems (bdds) quality investigated the complaint of a potential false positive biofire test result when used with bd bactec¿ peds plus¿/ f culture vial.The biofire bcid identified proteus in a positive patient blood culture bottle with the results being reported out after the patient expired.The patient was 3 months in age and had been in the nicu for an infection since birth.The caregivers were aware that the patient had an e.Coli infection prior to receiving the biofire results.The patient was treated with gentamicin and vancomycin.Proteus did not grow in culture nor was it seen on gram stain.According to the hospital the patient¿s death was not due to any changes in treatment.Bdds investigation findings to date are as follows: we have tested more than 400 samples for bioburden and/or molecular testing.No viable proteus organisms have been recovered in any sample including raw materials, in-process water, the deionized (di) water system, and the environmental samples throughout the manufacturing process.No proteus dna has been detected by molecular testing with biofire filmarray bcid assay in the water supply, the di water system and the environmental samples throughout the manufacturing process.Consistent with customer reports, some lots of final product tested positive for proteus sp with biofire filmarray bcid assay.There have been no recent changes to raw materials, design, manufacturing process, or distribution practices.The remainder of bdds investigation will focus on the following areas: additional testing of the dehydrated media and the raw material components.Cross-reactivity evaluation of purified cultures of environmental organisms found during bioburden testing.Testing of additional in-process samples.Further actions are to be determined based on the remaining investigation results.

Event Description

It was reported that biofire identified proteus in a bd bactec¿ peds plus¿/ f culture vial with results being reported out after the patient expired.The patient was three months in age and had been in the nicu for the infection since birth.The caregivers were aware that the patient had e.Coli prior to receiving the biofire results.The patient was treated with gentamicin and vancomycin.

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS
• Type of Device: CULTURE VIAL
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7562714
• MDR Text Key: 109848111
• Report Number: 2647876-2018-00017
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904421946
• UDI-Public: 00382904421946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 442194
• Device Lot Number: 8015973
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 3 MO