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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported an unknown patient required the placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for the drainage of an abdominal abscess.The operator reported placing the catheter with trocar style standard technique.Upon insertion, a contrast medium was injected and leakage was noted in two locations, at the "connection between the hub" and the catheter and in the "mac-loc area (around the string)." another similar device was opened for use, but the catheter was flushed prior to placement and leakage was confirmed on that catheter as well.The procedure was completed successfully by the placement of a competitor device.No other adverse events were reported.Patient identifier (b)(6) is related to the first catheter that was reported as leaking after insertion into the patient.Patient identifier (b)(6) is related to the opened catheter that was reported leaking prior to insertion into the patient (this report).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 25aug2020.Investigation ¿ evaluation: (b)(6) hospital in japan informed cook that a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked during a drainage procedure.The catheter was flushed prior to use and leaked at the hub and mac-loc lever.Another catheter was used to successfully complete the procedure.The patient did not experience adverse effects.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, visual inspection, functional test, and dimensional verification, were conducted during the investigation.The customer returned one prepped catheter.There is no visible biological matter.The mac-loc lever is unlocked.The device does not leak when flushed with water.The distance between the cap and the hub was measured and determined to be within specification.There is less that 1 adapter thread showing.There is no evidence the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include 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.Inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.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.The device history record (dhr) was reviewed for the lot to check for nonconformances.The lot had a nonconformance for "proximal end, incorrect" because there were too many adapter threads showing.The returned device had an adequate number of threads showing, therefore this nonconformance is not related to this complaint device.Additionally, a complaint database search was conducted for the reported lot.No additional complaints were found.There is no evidence of nonconforming material in house or in the field.A capa was previously opened to address this failure and identified manufacturing-related causes.The capa implemented corrective actions in response to this investigation.This complaint lot was manufactured prior to implementation of these actions.Based on the information provided, examination of returned product, manufacture date of the device, and the results of the investigation, cook concluded it is possible that quality control and manufacturing deficiencies contributed to this failure.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 10434344
• Report Number: 1820334-2020-01531
• Device Sequence Number: 13881072
• Product Code: GBO
• UDI-Device Identifier: 00827002137684
• UDI-Public: (01)00827002137684(17)220108(10)9428122
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 01/08/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-WF-HC
• Device Lot Number: 9428122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7 FR. CATHETER, UNKNOWN MANUFACTURER