MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367364

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).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 that foreign matter was found on the tubing of a bd vacutainer(r) ultratouch" push button blood collection set during use.There was no patient impact.The following information was provided by the initial reporter: the customer found black fm within the tubing and stopped the use.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/21/2020.H.6.Investigation: bd received 1 sample and 5 photos from the customer for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Additionally, the customer sample was evaluated by visual examination and the indicated failure mode for foreign matter 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 issues during manufacturing of the product.H3 other text : see h.10.

Event Description

It was reported that foreign matter was found on the tubing of a bd vacutainer® ultratouch¿ push button blood collection set during use.There was no patient impact.The following information was provided by the initial reporter: the customer found black fm within the tubing and stopped the use.

• Brand Name: BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 11096452
• MDR Text Key: 226092949
• Report Number: 1024879-2020-00969
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• PMA/PMN Number: K153309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 367364
• Device Catalogue Number: 367364
• Device Lot Number: 9352416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1