MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) WINGSET PBBCS 21 X .75 12 PREATTACHED; BLOOD COLLECTION SET

Catalog Number 367352

Device Problems Bent (1059); Break (1069)

Patient Problem No Information (3190)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

Results: batch 6021896 four customer samples were received with severed tubing.Batch 5343757 one customer sample was received with severed tubing.As this is a confirmed complaint a dhr review is not required refer to capa 50210 for investigation summary.Conclusion: capa (b)(4) has been initiated for documentation related to this issue of severed tubing to document the investigation path, root cause analysis and remediation plan to include corrective and preventive actions.Root cause: just before the sealing process if the tubing is hanging outside of the bottom blister cavity, the tubing can be severed.Remedial action required: capa (b)(4) has been initiated for this issue to document the investigation path, root cause analysis and remediation plan to include corrective and preventive actions.

Event Description

It was reported that before using the wingset pbbcs 21 x.75 12 preattached the user noted that the tubing was pinched and sometimes completely severed.

• Brand Name: WINGSET PBBCS 21 X .75 12 PREATTACHED
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6999550
• MDR Text Key: 92201041
• Report Number: 1024879-2017-00231
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673520
• UDI-Public: 00382903673520
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011984
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 367352
• Device Lot Number: 6021896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• 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