MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BARRICOR¿; BLOOD COLLECTION TUBE

Catalog Number 365039

Device Problem Suction Problem (2170)

Patient Problem Hematoma (1884)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Results: no samples were received from the customer in support of this complaint, however 2 photographs of a tube with a small amount of blood in were provided.10 retained tubes from the same lot number were draw tested with deionized water, and all drew within specification for a 5.5 ml draw product.A review of the device history record revealed no irregularities during the manufacture of the reported lot #5329523.Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure mode with the photos provided.An absolute root cause for this incident cannot be determined.

Event Description

It was reported that bd vacutainer® barricor¿ had minimal vacuum and as consequence did not draw blood correctly resulting in a hematoma.No medical intervention reported.

• Brand Name: BD VACUTAINER® BARRICOR¿
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7096743
• MDR Text Key: 94658400
• Report Number: 9617032-2017-00510
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

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: 05/31/2017
• Device Catalogue Number: 365039
• Device Lot Number: 5329523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2015
• 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