MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL CRYSTAL GRAM-POSITIVE ID SYSTEM; GRAM POSITIVE IDENTIFICATION PANEL

Model Number 245240

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

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter address:(b)(6).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 bbl¿ crystal¿ gram-positive id system atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

H.6.Investigation: this complaint is due to no taxa information for the identification of streptococcus saprophyticus when using crystal gram positive kit (245240) batch 288588.Lab result reports were provided by the customer, but no product returns or isolates were provided for investigation.To investigate, the taxa for crystal id was reviewed.This catalog number does not contain claims for streptococcus saprophyticus, therefore it is not within the list of taxa for this product.This complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed one (1) additional complaint for this batch, but not related to this defect.There are no trends for this defect type.

Event Description

It was reported that while using bd bbl¿ crystal¿ gram-positive id system atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: BD BBL CRYSTAL GRAM-POSITIVE ID SYSTEM
• Type of Device: GRAM POSITIVE IDENTIFICATION PANEL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11490586
• MDR Text Key: 242954546
• Report Number: 1119779-2021-00491
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 30382902452400
• UDI-Public: 30382902452400
• Combination Product (y/n): N
• PMA/PMN Number: K961968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/24/2021
• Device Model Number: 245240
• Device Catalogue Number: 245240
• Device Lot Number: 0288588
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1