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 Difficult or Delayed Activation (2577)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: intravascular administration set medical device type: (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 with the use of the bd vacutainer ultratouch push button blood collection set experienced a retraction issue - does not retract (button will not engage).The following information was provided by the initial reporter: the customer stated "inpatient phlebotomy has been experiencing issues with the butterfly needles.The needles are not retracting." this event occurred 1 time there was no exposure to blood/bodily fluids.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-30.H6: investigation summary: bd received one (1) empty pack from the customer for investigation.The returned sample were evaluated by visual examination and the indicated failure mode for retraction failure with the incident lot was not 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.

Event Description

It was reported with the use of the bd vacutainer® ultratouch¿ push button blood collection set experienced a retraction issue - does not retract (button will not engage).The following information was provided by the initial reporter: the customer stated "inpatient phlebotomy has been experiencing issues with the butterfly needles.The needles are not retracting." this event occurred 1 time there was no exposure to blood/bodily fluids.

• 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: 10782327
• MDR Text Key: 214597636
• Report Number: 1024879-2020-00787
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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: 0063473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1