MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® BLOOD COLLECTION TUBES

Catalog Number 365968

Device Problems Crack (1135); Fluid/Blood Leak (1250); Split (2537)

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

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Results - confirmed: bd life sciences - preanalytical systems was able to confirm the customer¿s indicated failure mode with one actual sample provided by the customer.The defect was not observed in the retention samples.A review of the manufacturing records was performed for the incident lot and no manufacturing issues were reported.Conclusion - the most probable root cause associated to the reported issue may be due to molding process issues.

Event Description

It was reported that during centrifugation, bd microtainer® blood collection tubes leaked.User reported seeing cracks and splits in the tubing.No injury or medical intervention reported.

Manufacturer Narrative

The initial mdr was submitted without a 510k number but this device 510k is k991702.

• Brand Name: BD MICROTAINER® BLOOD COLLECTION TUBES
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7077977
• MDR Text Key: 94737425
• Report Number: 2618282-2017-00031
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K991702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2017
• 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: 365968
• Device Lot Number: 7095632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• 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