MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE; BLOOD COLLECTION TUBE

Catalog Number 367861

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

Two separate lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 6102725, medical device expiration date: 08/31/2017, device manufacture date: 04/11/2016.Medical device lot #: 6090979, medical device expiration date: 08/31/2017, device manufacture date: 03/30/2016.(b)(6).Results: ten samples, five from each lot number, were returned for evaluation.All customer samples were draw tested and measured for overall tube height.Twenty retention samples were pulled, 10 samples from each lot, and were draw tested and measured for overall tube height.All tubes, both customer samples and retention samples, were within specification limits.There was no stopper pull out, creepout, or popoff observed during the draw testing.All tube height was within specification of no greater than 3.248.A device history record was not reviewed but there were no related quality notifications and all process and final inspections comply with specification requirements.Conclusion: 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.(b)(4).

Event Description

It was reported that the stopper of a bd vacutainer® plus plastic whole blood tube stayed connected to the needle, pulled out of the tube, and blood leaked when the tube was withdrawn from a holder during a blood collection.It was also reported that this has happened with different units (two lot numbers were provided) with different employees on numerous occasions.There was no report of injury or medical intervention.

• Brand Name: BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE
• 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: 6641984
• MDR Text Key: 77723021
• Report Number: 1917413-2017-00018
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K981013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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