MAUDE Adverse Event Report: COOK INC ULTRATHANE SIMP-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: "internal pharmacy".Initial reporter also sent report to fda: unknown.This device is currently restricted for sale in the us, however the authorization number is pma/510(k) #: k173035.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a ultrathane simp-loc locking loop multipurpose drainage catheter was used in an unknown patient during a visceral drainage procedure.During the procedure, a defect on the catheter was noted.The operator reported that "the needle was too short compared to the mandril." the device was replaced with another drain from the same lot.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.During preliminary evaluation of the device on (b)(6) 2019, it was observed that the catheter had been punctured by the needle.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: (b)(6) 2019.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complaint device was returned to cook for investigation.During investigation, the needle and cannula were found advanced into the catheter, with the tubing partially retracted.The needle was protruding through the back of the catheter.All dimensions deemed relevant to the reported failure mode were analyzed and found that the device was manufactured within specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record showed no relevant nonconformances for the complaint lot or related subassembly lots.A software search for complaints on the reported lot found no additional complaints.At this time, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE SIMP-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8935501
• MDR Text Key: 155691087
• Report Number: 1820334-2019-02130
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002062511
• UDI-Public: (01)00827002062511(17)191016(10)7363494
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2019
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-MSL
• Device Lot Number: 7363494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1