MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367290

Device Problem Product Quality Problem (1506)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported the bd vacutainer® multiple sample luer adapter experienced the hub separating from the device.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "they experienced multi sample adapter breaking in port.The customer requested help with correct technique used when accessing cvc.The staff had two instances when hooking it up into the arterial port of a cvc and it broke off.They were able to get one out of one patients the other had to go to the hospital and have it removed.".

Event Description

It was reported the bd vacutainer® multiple sample luer adapter experienced the hub separating from the device.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "they experienced multi sample adapter breaking in port.The customer requested help with correct technique used when accessing cvc.The staff had two instances when hooking it up into the arterial port of a cvc and it broke off.They were able to get one out of one patients the other had to go to the hospital and have it removed.".

Manufacturer Narrative

H6: investigation summary: bd had not received samples, but 1 photo was provided by the customer for investigation.The photo was reviewed and the indicated failure mode for luer adaptors breakage with the incident lot was observed.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 non-conformances during manufacturing of the product.

• Brand Name: BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 11125568
• MDR Text Key: 225359912
• Report Number: 1024879-2021-00010
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672900
• UDI-Public: 50382903672900
• Combination Product (y/n): N
• PMA/PMN Number: K991088
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 367290
• Device Catalogue Number: 367290
• Device Lot Number: 0167834
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other