MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367364

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: common device name: intravascular administration set; medical device type: fpa.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported before use of the bd vacutainer® ultratouch¿ push button blood collection set the tubing separated or kinked.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: "the tubing was found to be kinked before usage.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but [8] photos were provided for investigation.Evaluation of attached photographs indicated bent tubing.Additionally, [30] retention samples from bd inventory were evaluated by visual examination and the issue of kinked tubing was not observed.Bd was able to duplicate or confirm the customer¿s indicated failure mode with the photos provided.This complaint has been confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.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 before use of the bd vacutainer® ultratouch¿ push button blood collection set the tubing separated or kinked.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: "the tubing was found to be kinked before usage.".

Event Description

It was reported before use of the bd vacutainer® ultratouch¿ push button blood collection set the tubing separated or kinked.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: "the tubing was found to be kinked before usage.".

Manufacturer Narrative

The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 10-may-2023.Bd did receive 8 photographs and 7 samples from the customer in support of this complaint.Evaluation of attached photographs and returned samples indicated bent tubing.30 retained samples were visually inspected, and no damaged tubing was found.Bd was able to duplicate or confirm the customer¿s indicated failure mode with the returned samples and photos provided.This complaint has been confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.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.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16766350
• MDR Text Key: 313568763
• Report Number: 9617032-2023-00441
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367364
• Device Catalogue Number: 367364
• Device Lot Number: 2230228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/27/2023; 05/12/2023
• Supplement Dates FDA Received: 05/03/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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