MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD¿ VACUTAINER¿ PLASMA PREPARATION TUBE K2EDTA GEL ADDITIVE WITH BD HEMOGARD; BLOOD COLLECTION TUBE

Catalog Number 362795

Device Problem Defective Device (2588)

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

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter: address unavailable.Bd corporate address used for zip code, city, and address 1.Results: a sample was not returned for evaluation.A photo was sent that showed the defect.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5300868.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 plastic lip of the bd¿ vacutainer¿ plasma preparation tube k2edta gel additive with bd hemogard had a molding defect which allows blood to potentially flow out of the tube.No injury or medical intervention reported.

• Brand Name: BD¿ VACUTAINER¿ PLASMA PREPARATION TUBE K2EDTA GEL ADDITIVE WITH BD HEMOGARD
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7068511
• MDR Text Key: 94199582
• Report Number: 1917413-2017-00231
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K901449
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 362795
• Device Lot Number: 5300868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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