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

Model Number 367364

Device Problems Product Quality Problem (1506); Difficult or Delayed Activation (2577)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: medical device type: fpa.Investigation summary: bd had not received samples or photos for investigation.Therefore, 30 retention samples from bd inventory were evaluated by visual inspection and no issues were observed relating to damaged components (retraction failure) as all samples met specifications.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 is unable to be confirmed for the indicated failure mode damaged components (retraction failure).Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was a needle stick injury - post use and retraction issue- delay or no retraction.The following information was provided by the initial reporter.The customer stated: "sustained a needle stick injury while getting butter fly retracted post attempting blood collection of a patient.Was unable to retract butterfly sharp by using mechanism, sustained injury to left thumb.Attempted first aid at the scene.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12497519
• MDR Text Key: 272214867
• Report Number: 1024879-2021-00641
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 367364
• Device Catalogue Number: 367364
• Device Lot Number: 1096954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other