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

Catalog Number	C-PCS-830-LOCK
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510 (k) # exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The (b)(4) distributor reported that back hair was observed inside the primary package during inspection.There was no patient involvement.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, quality control, and visual inspection of the photos provided was conducted during the investigation.The complaint device was not returned.However, customer photos show one unopened product with visible foreign matter inside.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of device photographs, and the results of our investigation, the root cause of this defect was found to be manufacturing related.At the time of the manufacturing of this device, the failure mode of foreign matter in sealed packages had been escalated per internal processes.Per the quality engineering risk assessment, no further action is required.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.

• 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: 7450091
• Report Number: 1820334-2018-01020
• Device Sequence Number: 1052509
• Product Code: GBX
• UDI-Device Identifier: 00827002024335
• UDI-Public: (01)00827002024335(17)200502(10)7879640
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/04/2018

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: No Information
• Device Catalogue Number: C-PCS-830-LOCK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1