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

Catalog Number 021305

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: preamendment.The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported during a ureteroscopy procedure, upon opening the package, foreign matter was found in the sealed pouch on the luer lock of the open-end flexi-tip ureteral catheter.The procedure was completed successfully with another device from the same lot.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a physical examination of the returned device was performed.A review of the complaint history, the device history record, and specifications was also conducted.One open package labeled rpn 021305, label lot number 8128272 was received; the device appears to be unused.A strand of plastic like material was observed attached to the threads of the flla fitting.A review of the device history record found no non-conformances associated with the complaint device lot number 8128272.A review of complaint history revealed there are no other complaints associated with lot number 8128272.The customer-provided report stated that the reported foreign material appeared to be a strand of plastic-like material that was attached to the threads of the part.These strings are naturally occurring during the injection molding process, as a by-product of the mold design.Based on the provided information, and returned device, the cause appears to be a strand of plastic left from the supplier manufacturing process.The supplier has advised that a quality communication bulletin has been provided to the injection molding department for awareness of this defect.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7174513
• MDR Text Key: 96722773
• Report Number: 1820334-2018-00018
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)200809(10)8128272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 021305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1