MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® URINE COMPLETE CUP KIT; TRANSPORT CULTURE MEDIUM

Catalog Number 364956

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7206941, medical device expiration date: 2019-02-28, device manufacture date: 2017-07-25.(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® urine complete cup kit had erroneous results.No serious injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

Event Description

It was reported that bd vacutainer urine complete cup kit had erroneous results.No serious injury or medical intervention.

Manufacturer Narrative

Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for erroneous results with the incident lot was not observed as all product specifications were met.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Based on evaluation of the customer samples, the customer¿s indicated failure mode for erroneous results with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that bd vacutainer urine complete cup kit had erroneous results.No serious injury or medical intervention.

Manufacturer Narrative

Correction: a call was made to the customer to get name and email address to send the replacement request.The name, email address and phone number was updated.(b)(6).

Event Description

It was reported that bd vacutainer® urine complete cup kit had erroneous results.No serious injury or medical intervention.

• Brand Name: BD VACUTAINER® URINE COMPLETE CUP KIT
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7573346
• MDR Text Key: 110462208
• Report Number: 1917413-2018-02177
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: 50382903649568
• Combination Product (y/n): N
• PMA/PMN Number: K024240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 364956
• Device Lot Number: 7206938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other