MAUDE Adverse Event Report: COOK INC URODYNAMICS CATHETER; FAP CYTOMETRIC GAS (CARBON DIOXIDE

Catalog Number	020207
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.(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
It was reported, prior to opening the sterile package of the urodynamics catheter, a "hair like" material was observed inside the package.No patient involvement.
Additional Manufacturer Narrative
Evaluation conclusion code: quality control deficiency (143).Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, quality control data, and specifications.One unopened package labeled rpn 020207 with label lot number 8513243 was received.Visual examination of the package confirmed a hair dark in color is loose inside the sealed package.The device history record was reviewed and no non-conformances were noted.A search of complaint records revealed this is the only complaint associated with complaint lot number 8513243.This complaint is confirmed based on the returned device.The cause has been traced to manufacturing; a quality control deficiency.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is warranted.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: URODYNAMICS CATHETER
• Common Device Name: FAP CYTOMETRIC GAS (CARBON DIOXIDE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7758010
• Report Number: 1820334-2018-02353
• Device Sequence Number: 1756898
• Product Code: FAP
• UDI-Device Identifier: 00827002154292
• UDI-Public: (01)00827002154292(17)210116(10)8513243
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K915443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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 Expiration Date: 01/16/2021
• Device Catalogue Number: 020207
• Device Lot Number: 8513243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1