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 Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (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 after using the bd vacutainer® ultratouch¿ push button blood collection set, blood leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: after using the needle, the blood has been bleeding.

Event Description

It was reported that after using the bd vacutainer® ultratouch¿ push button blood collection set, blood leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: after using the needle, the blood has been bleeding.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/28/2020.H.6.Investigation: bd received one (1) sample and two (2) photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for leakage with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for leakage with the incident lot was observed.Based on the customer photos and sample provided, the most likely root cause of the sleeve leakage is the np cannula piercing the side of the rubber sleeve.As there is a vision system for the detection of side pierce sleeves, the most likely root cause is that the product was pushed off to the rework table and inadvertently not discarded by a production associate.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.

• 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: 11097612
• MDR Text Key: 226227635
• Report Number: 1024879-2020-00975
• 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: 02/08/2021

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: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 367364
• Device Catalogue Number: 367364
• Device Lot Number: 0041069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1