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

Device Problem Gas/Air Leak (2946)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was to be used for an abscess drainage in the abdomen.An air leakage between the catheter and mac-loc was observed during preparation for the procedure and the device did not make patient contact.It was confirmed that the suture string remained intact during the procedure.This report references one incident of air leakage.The other two are captured in reports with patient identifier: (b)(6).No other adverse effects were reported for this incident.

Manufacturer Narrative

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.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: d10, h6 - annex f investigation ¿ evaluation on 23aug2022, cook korea received a complaint from a representative at the (b)(6) hospital.During the preparation of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-5s-cldm-hc, lot: ns14489325), leakage was observed at the cap and hub connection site.This occurred with three devices of the same lot.The device did not make contact with the patient.The other two devices are reported under medwatch reference numbers 1820334-2022-01456 and 1820334-2022-01474.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure prior to distribution.A review of the device history record (dhr) for lot ns14489325 and mac-loc hub subassembly lot sa14399853 found no relevant nonconformances that could have contributed to the reported failure mode.Additionally, a review of the torque driver used during the processing of the reported lot , confirmed no evidence of manufacturing deficiency.Since this customer reported three separate incidents, involving the same lot for leakage at the catheter / hub connection site, an expanded search containing the mac-loc hub subassembly, (lot sa14399853) was discovered to have been applied to 21 additional lots.A review of these lots confirmed that no other complaints have been received for leakage at the hub / catheter connection site.However, 9 of the lots had recorded nonconformances possibly relevant to the reported difficulty.All nonconforming devices were scrapped prior to further processing of the orders.It should be noted that there were two other complaints associated with the final product number from the same facility for the same failure.Cook also reviewed product labeling.The instructions for use (ifu) [ t_multi2_rev1, ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter] states the following.How supplied: "upon removal from package, inspect the product to ensure no damage has occurred." evidence gathered upon review of the dmr, dhr and ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no returned product, and the results of our investigation, it was concluded that a component failure without any design or manufacturing issue contributed to the reported incident.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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
• 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: 15394602
• MDR Text Key: 306079125
• Report Number: 1820334-2022-01475
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)250121(10)NS14489325
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: NS14489325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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
• Treatment: TERUMO WIRE GUIDE