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

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

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 Description

It was reported the packaging of an ultrathane mac-loc locking loop multipurpose drainage set was perforated.The failure was discovered by the distributor upon receipt of the device.There was no patient involvement.

Manufacturer Narrative

Additional information: b3- date of event is approximately 15feb2022.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 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 unknown, unchanged or unavailable.Investigation ¿ evaluation bemel logistics/advanced (columbia) informed cook on 16mar2022 of an incident involving a ultrathane mac-loc locking loop multipurpose drainage set (rpn: clm-10.2-rh-npas-nt, lot: 14003342).It was reported that the packaging of a ultrathane mac-loc locking loop multipurpose drainage set from the same lot was found to be perforated upon receipt.No adverse effects to the patient were reported as this was found prior to use.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 unopened clm-10.2-rh-npas-nt was returned for evaluation.A visual examination of the device found the lower left side packaging was torn.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14003342 found no nonconformances.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The product ifu, [t_multi_rev5 ] ¿multipurpose drainage catheters,¿ 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 or 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.¿ evidence gathered upon review of the dmr, dhr, ifu, provided photos, and investigation of the returned device, suggests that there is no evidence the device was manufactured out of specification, or that there are non-conforming devices in house or out in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that the device was likely damaged during shipping and handling.There are 100% inspection activities in place to identify this failure prior to distribution.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 Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET
• 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: 13966425
• MDR Text Key: 291327405
• Report Number: 1820334-2022-00498
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002100503
• UDI-Public: (01)00827002100503(17)240922(10)14003342
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

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 Model Number: N/A
• Device Catalogue Number: CLM-10.2-RH-NPAS-NT
• Device Lot Number: 14003342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/13/2022; 11/11/2022
• Supplement Dates FDA Received: 04/27/2022; 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• 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