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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the hub of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter broke prior to use.A photo provided by the customer shows the hub of the catheter separated from the catheter shaft.Another product was opened to complete the biliary drainage procedure successfully.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.On 11jan2022 cook india received a complaint from dr.(b)(6) , a representative at the (b)(6), located in the city of (b)(6).It was reported that during the prepping process of the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (ult14.0-38-25-p-5s-cldm-hc; lot: #13997224), the catheter separated from the hub.The procedure was completed using another device.There was no patient contact made, and no adverse effects were reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu) and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The device was returned in an opened, prepped but damaged condition.The catheter was received with the metal stiffener inserted into the mac-loc and catheter, with the proximal end of the catheter separated from the mac-loc adaptor.The cap and mac-loc adaptor were dissembled, confirming there was no catheter material caught between the cap and adaptor.A visual examination discovered the flare not to be of size and exhibiting a slant with unevenness.There was evidence of material elongation in the flare.Based on the evidence displayed, cook medical concluded the flare was manufactured out of specification.As a result of this discovery, a defect awareness retraining form was issued to the appropriate individual responsible for the flaring of the catheter.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.The risk specifications covering mac-loc drainage catheters includes hub separation as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.Cook reviewed the device history record (dhr).The dhr for lot 13997224, subassembly lots sa13822623 and sa13851771, and raw material lot 2127673.1 all record no relevant nonconformances or additional complaints.Based on this information, cook did not conclude that additional nonconforming material was in house or in the field.Cook also reviewed product labeling.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.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.It was determined 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.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: 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: 13286041
• Report Number: 1820334-2022-00083
• Device Sequence Number: 4280929
• Product Code: GBO
• UDI-Device Identifier: 00827002104365
• UDI-Public: (01)00827002104365(17)240601(10)13997224
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-25-P-5S-CLDM-HC
• Device Lot Number: 13997224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male