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

Model Number G14016

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

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 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.

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 Description

No new patient or event information has been reported since the last report was submitted.

• Brand Name: FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8480618
• MDR Text Key: 140944534
• Report Number: 1820334-2019-00650
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002140165
• UDI-Public: (01)00827002140165(17)201128(10)8400477
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1