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

Model Number 364953

Device Problems Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/29/2021

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® c&s transfer straw kit, the device experienced missing component.This event occurred two times.The following information was provided by the initial reporter.The customer stated: it is reported customer received an additional needle straw without a hub in a sealed package."just wanted to give you a heads up ¿ florence found 2 c&s straw kits with an extra needle in them.One of our caregivers got stuck when she was grabbing a kit.I reported it to the other sites but haven¿t heard yet if anyone else has witnessed this.I am going to report it to the manufacturer today as well.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for incorrect packaging was observed as the photo shows the presence of an extra straw and needle assembly and the holder was missing from this assembly.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of incorrect packaging was not observed as there were no needle separation and had all correct components identified.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.This complaint has been confirmed for the indicated failure mode of incorrect packaging based on the photo provided.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® c&s transfer straw kit, the device experienced missing component.This event occurred two times.The following information was provided by the initial reporter.The customer stated: it is reported customer received an additional needle straw without a hub in a sealed package."just wanted to give you a heads up ¿ florence found 2 c&s straw kits with an extra needle in them.One of our caregivers got stuck when she was grabbing a kit.I reported it to the other sites but haven¿t heard yet if anyone else has witnessed this.I am going to report it to the manufacturer today as well.".

• 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: 12339886
• MDR Text Key: 267275666
• Report Number: 1917413-2021-00772
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: 364953
• Device Catalogue Number: 364953
• Device Lot Number: 1068737
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1