MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH; BLOOD COLLECTION/INTRAVENOUS FLUID ADMINISTRATION SET

Catalog Number 367364

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.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 a bd vacutainer® ultratouch¿ push was leaked at the root of needle during use.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for sleeve leakage (non-patient end cannula) with the incident lot was observed.However, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for sleeve leakage (non-patient end cannula) with the incident lot was observed.Root cause description: based on the investigation, a root cause could not be determined.

Event Description

It was reported that a bd vacutainer® ultratouch¿ push was leaked at the root of needle during use.

Event Description

It was reported that a bd vacutainer® ultratouch¿ push was leaked at the root of needle during use.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH
• Type of Device: BLOOD COLLECTION/INTRAVENOUS FLUID ADMINISTRATION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8204015
• MDR Text Key: 131711908
• Report Number: 1024879-2018-01525
• 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,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other