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 Code Available (3191)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(4).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 a female patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for an left axilla abscess drainage procedure.After placement, the operator noticed "the drain could not maintain a seal and so suction was not possible".The dressing was reinforced and the device was kept "insitu for a few hours".Suction was not achieved, so the drain was replaced with a new similar device.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned so a physical examination could not be performed.Since relevant dimensions could not be measured against specification, the device cannot be confirmed to be 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.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.A review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots revealed no reported nonconformances.A database search revealed no other complaints from the complaint lot at the time of investigation.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.Based on the information provided, inspection of the returned product and the results of the investigation, it was concluded that a manufacturing and quality control deficiency possibly contributed to this incident.Corrective actions including implementation of a gap gauge and retraining were performed.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 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
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9460018
• MDR Text Key: 179412251
• Report Number: 1820334-2019-03094
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002113862
• UDI-Public: (01)00827002113862(17)220425(10)9694953
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-15-P-5S-CLDM-HC
• Device Lot Number: 9694953
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR