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

Catalog Number 367365

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

Results - (b)(4) customer samples were received for evaluation by (b)(4).Visual inspection of the samples with 10x magnification identified nicks in the tubing approximately 2¿ from the iv hub when the needle is in the retraction mode.The two samples were leaked tested under pressurized conditions for leakage.There was no leakage in the tubing.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion - bd was not able to duplicate or confirm the customers indicated failure mode.

Event Description

It was reported that bd vacutainer® ultratouch¿ push button blood collection set had holes which resulted in blood leaking when drawing blood.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7117113
• MDR Text Key: 95079611
• Report Number: 1024879-2017-00959
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673655
• UDI-Public: 50382903673655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 367365
• Device Lot Number: 6165646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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