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	Exposure to Body Fluids (1745)
Date of Event	05/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: a customer provided a photo that shows a sample with a sliced area in the tubing however a sample was not returned for evaluation.A sample was not returned for evaluation.Conclusion: without a sample, 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.Possible root cause: just before the sealing process if the tubing is hanging outside of the bottom blister cavity, the tubing can be severed or sliced.A dhr review is not required.Refer to capa (b)(4) for complete documentation and action plans.Capa (b)(4) has been initiated for documentation related to this issue of severed/sliced tubing 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 while a nurse was using the wingset pbbcs 21 x.75 12 pre-attached to draw blood there was blood leakage out of the tubing.Upon examination, tubing was found to be defective with visible severed sliced tubing.There were two separate incidents: one in which the leaking blood contacted a nurse's gloved hands and a second incident when the blood leaked on the nurse's watch and arm.No blood exposure to open skin or mucosal membranes.No injure or medical intervention.

• 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: 6999664
• Report Number: 1024879-2017-00241
• Device Sequence Number: 16433395
• 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: Nurse
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 367352
• Device Lot Number: 6021896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2016
• 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