MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Model Number 364958

Device Problem Overfill (2404)

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

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube there was overfill.The following information was provided by the initial reporter: translated to english.The customer stated: "tubes are filled completely which lead to problems from a technical point of view.".

Event Description

It was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube there was overfill.The following information was provided by the initial reporter: translated to english.The customer stated: "tubes are filled completely which lead to problems from a technical point of view.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-03-15.H6: investigation summary.Bd received twenty-one (21) samples and two (2) photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for overfill with the incident lot was not observed.Additionally, the customer samples were evaluated by functional testing and the indicated failure mode for overfill with the incident lot was not observed as all product specifications were met.Per specification for this product, there is only a minimum fill line.There is no maximum fill line required.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 issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.

• Brand Name: BD VACUTAINER BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11544359
• MDR Text Key: 260965120
• Report Number: 1917413-2021-00211
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 50382903649582
• UDI-Public: 50382903649582
• Combination Product (y/n): N
• PMA/PMN Number: K024240
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 364958
• Device Catalogue Number: 364958
• Device Lot Number: 0343473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1