MAUDE Adverse Event Report: COOK INC FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number	G14016
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k): pre-amendment.(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 a strand of hair was found in the sealed packaging of the flexi-tip ureteral catheter.The device was not used.The procedure was successfully completed with another device.
Additional Manufacturer Narrative
Investigation/evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, and quality control data.One unopened device confirming this lot number was returned for investigation.Visual examination of the package confirmed dark hair like foreign matter inside the sealed package.A review of the device history record for this lot number showed no non-conformances that would have caused or contributed to the reported failure mode.A review of complaint history revealed no other complaints associated with this lot number.A review of this lot number shipment history found all of this lot number has been shipped.The last product from this lot number shipped march, 2018.The returned device confirmed the customers complaint that a hair like fiber was sealed inside the package.The cause of the failure mode has been contributed to by the manufacturing process.The dmr review identified that controls are in place, the flexi-tip ureteral catheters are inspected after being packaged for foreign matter.Due to the individual nature of the inspection of the packaged product one nonconformance does not indicate additional non conformances in the lot.Additionally, there have been no other complaints filed for this lot.Therefore, there is no evidence to suggest that nonconforming product are in the field; the investigation conclusion is the cause of this failure mode has been traced to manufacturing process.Per the quality engineering risk assessment, risk mitigation was not required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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
No new patient or event information has been reported since the last report was submitted.

• Brand Name: FLEXI-TIP URETERAL CATHETER
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8480618
• Report Number: 1820334-2019-00650
• Device Sequence Number: 1920005
• Product Code: GBL
• UDI-Device Identifier: 00827002140165
• UDI-Public: (01)00827002140165(17)201128(10)8400477
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 11/28/2020
• Device Model Number: G14016
• Device Catalogue Number: 021105
• Device Lot Number: 8400477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1