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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported foreign matter was found in the packaging of an ultrathane mac-loc locking loop multipurpose drainage set.The failure was discovered by the distributor upon receipt of the device.There was no patient involvement.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b3- date of event is approximately 25feb2022.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 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.
Additional Manufacturer Narrative
Investigation evaluation: ifs miami (columbia) informed cook on 16mar2022 of an incident involving an ultrathane mac-loc locking loop multipurpose drainage set (rpn: clm-8.5-rh-npas-nt, lot: 14254422).It was reported that upon receiving the device it was noticed that there was foreign matter inside the package.This device did not make patient contact, and no adverse effects were reported to the patient due to this occurrence.Reviews of the documentation, including the complaint history, device history record, 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 and sealed device was returned for evaluation.Upon visual inspection, it was noted there was foreign matter from an unknown source near the bottom of the inner package.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 dhr for lot 14254422 records no non-conformances that could have contributed to the reported failure mode.A database search for complaints on the reported lot found one complaint from the field (mfg.Report reference #: 1820334-2022-00493) for an unrelated failure mode.Cook also reviewed product labeling.The current instructions for use [t_multi_rev5] state the following: "how supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use this 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." evidence gathered upon review of product labeling, dmr and dhr, did not confirm that the device was manufactured out of specification or items in the lot or similar devices in the field or in house are nonconforming.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that this occurred due to a quality control deficiency.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.
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 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: 13966051
• Report Number: 1820334-2022-00496
• Device Sequence Number: 11982560
• Product Code: GBO
• UDI-Device Identifier: 00827002100497
• UDI-Public: (01)00827002100497(17)241109(10)14254422
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/15/2022

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
• Device Expiration Date: 11/09/2024
• Device Model Number: N/A
• Device Catalogue Number: CLM-8.5-RH-NPAS-NT
• Device Lot Number: 14254422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 11/11/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/27/2022; 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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 Sex: Unknown