MAUDE Adverse Event Report: COOK INC LOCK PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported by the distributor that there was a hair inside a sterile lock pericardiocentesis catheter set.No patient contact was made.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d10 - product received on investigation - evaluation: a review of the complaint history, device history record (dhr), instructions for use (ifu) and quality control, as well as a visual inspection of the returned device was conducted during the investigation.One sealed lock pericardiocentesis catheter set was returned to cook for evaluation.Upon visual inspection, a dark, hair-like fiber was observed in the sealed pouch.Therefore, this device was considered to be manufactured out of specification.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the complaint lot (9604205) revealed no reported non-conformances.A database search found this to be the only complaint associated with the given complaint lot.Due to this, cook has concluded that there is no evidence to suggest that non-conforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use states to "not use the product if there is doubt the product is sterile." based on the information provided, inspection of the returned product, and the results of our investigation, a definitive root cause was traced to a deficiency in manufacturing and more specifically in quality control.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: LOCK PERICARDIOCENTESIS CATHETER SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9209242
• Report Number: 1820334-2019-02648
• Device Sequence Number: 3057962
• Product Code: GBX
• UDI-Device Identifier: 00827002024335
• UDI-Public: (01)00827002024335(17)220319(10)9604205
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PCS-830-LOCK
• Device Lot Number: 9604205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1