MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINALYSIS TRANSFER STRAW KIT; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364991

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: no samples and 1 photo were returned by the customer in support of this complaint.Visual examination of photo was performed and revealed needle separation.Bd was able to confirm the customer¿s indicated failure mode with the photo provided.Bd was not able to identify a root cause for the indicated failure mode.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 complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® urinalysis transfer straw kit the reporter experienced the needle inside the transfer straw was dislodged and loose from the straw.The following information was provided by the initial reporter.The customer stated: "it was reported that the needle separated and was sticking through the package.The device/tube set up used everywhere in the hospital - the straw disconnected from the vacutainer portion and the large needle was sticking through the package.Tech went to grab a package in the drawer and almost got stuck.".

• Brand Name: BD VACUTAINER URINALYSIS TRANSFER STRAW KIT
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11345424
• MDR Text Key: 263965578
• Report Number: 1917413-2021-00107
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 364991
• Device Lot Number: 0120079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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