MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER Z (NO ADDITIVE) PLUS URINE TUBE; TRANSPORT CULTURE MEDIUM

Catalog Number 364915

Device Problem Overfill (2404)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using a bd vacutainer® z (no additive) plus urine tube stopper overfilling occurred.The following information was provided by the initial reporter, translated from (b)(6) to english: " urethra are too full 11 ml urethra too full for automatic processing".

Event Description

It was reported that while using a bd vacutainer® z (no additive) plus urine tube stopper overfilling occurred.The following information was provided by the initial reporter, translated from dutch to english: " urethra are too full 11 ml urethra too full for automatic processing".

Manufacturer Narrative

H6: investigation summary bd had not received samples, but one (1) photograph was supplied, this photo of the tube showed the same results as the draw testing done on the twenty (20) retained samples from batch 0094557 were draw-tested with deionized water.The water is drawn from a compensated draw apparatus.This comprises of a header tank, which is connected via tubing to a direct draw adapter at the end, into which the tube is inserted.The level at which the tube is inserted into the apparatus, is determined by local atmospheric pressure.This simulates the blood drawing method.Then the drawn tubes are weighed on a calibrated balance.From this testing it was determined that all twenty (20) tubes drew within specification.The reported failure mode of draw volume was not confirmed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.See h.10.

• Brand Name: BD VACUTAINER Z (NO ADDITIVE) PLUS URINE TUBE
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 10751993
• MDR Text Key: 214803827
• Report Number: 9617032-2020-00846
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 364915
• Device Lot Number: 0094557
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other