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

Catalog Number 364953

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

Material no.364953, batch no.Unknown.It was reported that after use of the bd vacutainer® c&s transfer straw kit there was a loose transfer needle in the bag with the transfer device which cause a needle stick injury.Tech was seen by urgent care provider.The following information was provided by the initial reporter: in bd vacutainer c&s transfer straw kit there was a loose transfer needle in the bag with the transfer device.The tech did not see the loose needle when she opened the bag to use the straw device, and when she went to throw away what she thought was an empty bag, she punctured her finger with the loose transfer needle.The transfer device in that bag was intact, meaning that the needle was installed in the device, but there was an ¿extra¿ loose needle in the bag.That is the one that punctured her finger.

Event Description

Material no.364953, batch no.Unknown.It was reported that after use of the bd vacutainer® c&s transfer straw kit there was a loose transfer needle in the bag with the transfer device which cause a needle stick injury.Tech was seen by urgent care provider.The following information was provided by the initial reporter: in bd vacutainer c&s transfer straw kit there was a loose transfer needle in the bag with the transfer device.The tech did not see the loose needle when she opened the bag to use the straw device, and when she went to throw away what she thought was an empty bag, she punctured her finger with the loose transfer needle.The transfer device in that bag was intact, meaning that the needle was installed in the device, but there was an ¿extra¿ loose needle in the bag.That is the one that punctured her finger.

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.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.

• Brand Name: BD VACUTAINER® C&S TRANSFER STRAW KIT
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9437679
• MDR Text Key: 178629667
• Report Number: 1917413-2019-02483
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 50382903649537
• UDI-Public: 50382903649537
• 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
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 364953
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other