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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Occupation: ir tech.Pma/510(k) #: exempt.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 an ultrathane mac-loc locking loop multipurpose drainage catheter leaked at the hub.When the device was hooked up to a drainage bag and flushed, air was leaking into the bag tubing.The drainage bag was disconnected and flushed again, and the leakage was noted where the mac-loc connects o the drainage bag.The device did not make patient contact and the procedure was completed with a similar device.No adverse effects were reported.

Manufacturer Narrative

Investigation ¿ evaluation: on 10may2022, cook medical received a complaint from a representative at the (b)(6) hospital, located in the (b)(6).During preoperative preparation, leakage was observed between the catheter tubing and hub of the ultrathane mac-loc locking loop multipurpose drainage catheter (ult10.2-38-25-p-6s-clm-rh; lot: 14440554).This occurred prior to patient contact; there was no impact to the patient.The procedure was completed by using another new device.No adverse effect reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.One used device drainage catheter received in an opened and prepped condition.A leak test confirmed fluid escaping from the catheter at the cap/tubing connection site.Additional investigation confirmed there was one thread showing between the mac-loc adapter and connector cap.The cap and mac-loc adaptor were disassembled and the flare was observed to exhibit a crease, leading to leakage.Based on the findings during the investigation, cook medical inc.Has concluded the device was manufactured out of specification.As a result of this discovery, the appropriate manufacturing personnel was notified.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.This device is 100% inspected for this failure in process.Cook reviewed the device history record lot 14440554, discovering two nonconformances recorded for "flare inadequate" that could be relevant to the reported difficulty.These devices were scrapped prior to the further processing.The mac-loc assembly, lot number sa14410373 had zero recorded nonconformances.A further search of the reported lot number confirmed no additional complaints being received.Cook also reviewed product labeling.The product ifu, [t_multi_rev5] ¿multipurpose drainage catheter,¿ provides the following information to the user related to the reported failure mode: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ instructions for use: ¿under fluoroscopic control, perform standard techniques for placement of percutaneous draining catheters, either by seldinger access or trocar access.Once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to for its configuration.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ upon a review the dmr, dhr, and ifu there is no evidence to suggest all items in the lot or similar devices in house or in the field are non-conforming.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to a manufacturing deficiency.The evidence displayed, concluded the flare was manufactured out of specification.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 MAC-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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14464035
• MDR Text Key: 292507464
• Report Number: 1820334-2022-00951
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)241228(10)14440554
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

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 Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 14440554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1