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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unidentified foreign particle was discovered within the sealed packaging of an ultrathane mac-loc locking loop multipurpose drainage set during device check in with the distributor.No patient contact was made, as the complaint device did not go to any clinic or hospital.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Initial reporter name and address : (b)(6).Occupation: regulator affairs chief.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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d9 (product returned date).Investigation-evaluation.On 18jan2023 cook medical incorporated received a complaint from a representative of the atilio palmieri s.R.L.Facility, peru, south america.It was reported that an unidentified foreign particle was discovered within the sealed packaging of an ultrathane mac-loc locking loop multipurpose drainage set (rpn: clm-8.5-rh-npas-nt; lot: 14832582) during device check in with the distributor.No patient contact was made, as the complaint device did not go to any clinic or hospital.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.One unused/sealed device was received.Upon a visual inspection, an unidentifiable section of foreign matter was confirmed to be present within the sealed packaging.Additionally, 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 mode prior to distribution.A review of the dhrs for the reported complaint device lot 14832582 confirmed there were no related non-conformances for foreign matter.A database search showed no other complaints were noted from this lot.An expanded search on lots processed having the same packaging operator was reviewed from 13sep2022 through 15sep2022.A total of 21 lots were identified.There have been no other foreign matter related complaints on these lots.Based on the collected information, it is feasible to conclude this is likely an isolated incident.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: the product ifu, [t_multi2_rev1] ¿multipurpose drainage catheter", provides the following information to the user related to the reported failure mode: ¿how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and 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.¿ this complaint has been confirmed based on the customers testimony and device evaluation.The customer reported that there was foreign matter within the sealed packaging.Based on visual inspection of the returned device, an unidentifiable section of foreign matter, brown in color was confirmed to be present within the sealed packaging.Cook concluded the cause of event to be a manufacturing deficiency.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 MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET
• 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: 16620182
• Report Number: 1820334-2023-00317
• Device Sequence Number: 20612612
• Product Code: GBO
• UDI-Device Identifier: 00827002100497
• UDI-Public: (01)00827002100497(17)250830(10)14832582
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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 Expiration Date: 08/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CLM-8.5-RH-NPAS-NT
• Device Lot Number: 14832582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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 Sex: Unknown