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

Catalog Number	367352
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/16/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 6999550
• Report Number: 1024879-2017-00231
• Device Sequence Number: 900242
• Product Code: JKA
• UDI-Device Identifier: 00382903673520
• UDI-Public: 00382903673520
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2016
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other