MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE TRANSFER STRAW; TRANSPORT CULTURE MEDIUM

Catalog Number 364940

Device Problem Break (1069)

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

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: na.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® urine transfer straw, the device experienced the transfer straw breaking off during use.The following information was provided by the initial reporter.The customer stated: we have received a defective batch of transfer cannula ref (b)(4) lot 1251392 on the sigean site.1 out of 2 cannulas broke during use.We had ordered 10 boxes.

Manufacturer Narrative

H.6.Investigation: 1 photo was returned by the customer in support of this complaint.A visual examination of photo was performed and the customer's indicated failure mode of separation was observed.The photo shows the holder has become separated from the straw and needle assembly.Bd was able to confirm the customer¿s indicated failure mode with the photo provided.The root cause of the customer¿s failure mode could not be determined.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.

Event Description

It was reported when using the bd vacutainer® urine transfer straw, the device experienced the transfer straw breaking off during use.The following information was provided by the initial reporter.The customer stated: we have received a defective batch of transfer cannula ref 364940 lot 1251392 on the sigean site.1 out of 2 cannulas broke during use.We had ordered 10 boxes.

• Brand Name: BD VACUTAINER® URINE TRANSFER STRAW
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14138422
• MDR Text Key: 289512623
• Report Number: 1917413-2022-00207
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364940
• Device Lot Number: 1251392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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