MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2EDTA TUBE WITH A PINK BD HEMOGARD¿; BLOOD COLLECTION TUBE

Catalog Number 367846

Device Problems Leak/Splash (1354); Defective Device (2588)

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

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Results: a sample was sent to bdj for evaluation.Bdj did confirm via air leak out bottom of tube.A photo was returned and showed the customers indicated failure of leakage from defect.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5041989.Conclusion: confirmed complaint.Defect is called a double shot defect from plastic molding on bottom of tube and is being related to manufacturing process.The most likely root cause for this is a part sticking to the mold.

Event Description

It was reported that a 2 ml, 13 mm x 75 mm bd vacutainer® k2edta tube with a pink bd hemogard¿ had a small defect that caused leakage on the bottom of tube.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: BD VACUTAINER® K2EDTA TUBE WITH A PINK 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: 7079971
• MDR Text Key: 94410524
• Report Number: 1917413-2017-00190
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981013
• 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: 11/02/2017

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: 05/31/2016
• Device Catalogue Number: 367846
• Device Lot Number: 5041989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2015
• Initial Date FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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