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

Catalog Number 367364

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

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 that the tubing of the bd vacutainer® ultratouch¿ push button blood collection set was damaged and caused blood leakage.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Bd received a used sample from the customer facility for investigation.The sample was evaluated and the customer's indicated failure mode for a cut in the tubing of the incident lot was observed.However, bd was unable to determine the specific lot number associated with this complaint as the product packaging/labelling was not received.Therefore, a review of the device history record could not be conducted.Based on evaluation of the customer samples, the customer¿s indicated failure mode for a cut in the tubing of the incident lot was observed.Based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.As a result, bd is reviewing specific areas in the manufacturing process where the cause of this issue may have originated.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the tubing of the bd vacutainer ultratouch push button blood collection set was damaged and caused blood leakage.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no, device returned to manufacturer: yes.

Event Description

It was reported that the tubing of the bd vacutainer® ultratouch¿ push button blood collection set was damaged and caused blood leakage.There was no report of exposure, injury, or medical intervention noted.

• 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: 7686564
• MDR Text Key: 114029382
• Report Number: 1024879-2018-00342
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673643
• UDI-Public: 00382903673643
• 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,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367364
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other