MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX SET; JOL CATHETER AND TIP, SUCTION

Catalog Number	C-UTPT-1400-WAYNE-IMH
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: exempt.Device evaluation: the reported device was not returned to cook inc.For evaluation.Photographs were sent and foreign matter, hair, is confirmed to be inside the sealed package.Investigation: a document-based investigation reviewed the following: instructions for use, quality control, complaint history, manufacturing instructions and device history record.A 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.There is no evidence to suggest there are non-conforming devices in house or in field.Conclusion: based on the information provided, examination of product photographs and the results of our investigation, the cause is traced to manufacturing.Per the [quality engineering] risk assessment, no further action is required.This defect can be easily identified prior to use with the naked eye.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported foreign matter, black hair, was found during incoming inspection in a sealed wayne pneumothorax set.The reported product did not make patient contact.

• Brand Name: WAYNE PNEUMOTHORAX SET
• Common Device Name: JOL CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8248383
• Report Number: 1820334-2019-00153
• Device Sequence Number: 1557716
• Product Code: JOL
• UDI-Device Identifier: 00827002565333
• UDI-Public: (01)00827002565333(17)200323(10)8767351
• 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
• Report Date (Section B): 01/15/2019

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: No Information
• Device Expiration Date: 03/23/2020
• Device Catalogue Number: C-UTPT-1400-WAYNE-IMH
• Device Lot Number: 8767351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1