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

Catalog Number 367338

Device Problems Fluid/Blood Leak (1250); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6172845.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that the the rubber sleeve of 21 g x.75 in bd vacutainer® winged safety push button blood collection set stuck on the cannula causing blood to leak at tube removal.No blood exposure to mucous membrane.No medical intervention or injury reported.

• Brand Name: BD VACUTAINER® WINGED SAFETY 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: 7098658
• MDR Text Key: 94970133
• Report Number: 1024879-2017-00914
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673389
• UDI-Public: 50382903673389
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 367338
• Device Lot Number: 6172845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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