MAUDE Adverse Event Report: COOK INC POLYETHYLENE ANGIOGRAPHIC CATHETER

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Common device name: device not cleared for sale in the us, similar product with procode dqo is cleared for sale in usa.Catalog #: p7.2-38-35-p-5s-pig-hirata-011480.Occupation: unknown.Pma/510(k) #: device not cleared for sale in the us.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, the distributor found "black foreign matter" inside of the sealed package of a polyethylene angiographic catheter prior to delivery to a hospital.There was no patient involvement.No other adverse effects were reported for this incident.

Manufacturer Narrative

D10 ¿ product received on: 02jun2020.Investigation ¿ evaluation: it was reported that a polyethylene angiographic catheter had black foreign matter in the sterilized sealed package prior to delivery to a hospital.This incident was reported by a distributor in japan.No adverse effects were reported.A review of the complaint history, device history record, instructions for use (ifu), and quality control of the device, as well as a visual inspection, were conducted during the investigation.The complainant returned a polyethylene angiographic catheter to cook for investigation.Physical/visual examination of the returned device showed a sealed device with two black specs in the pouch.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The product labeling was reviewed.The product ifu provides the following information to the user related to the reported failure mode: how supplied ¿do not use the product if there is doubt as to whether the product is sterile.¿ a review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the reported lot record recorded no related nonconformances.A data base search revealed no additional complaints for the complaint lot from the field.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, the examination of foreign matter sealed inside the unopened device, and the results of the investigation, it was concluded that a manufacturing and quality control deficiency was the main cause of 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 Description

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

• Brand Name: POLYETHYLENE ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10030304
• MDR Text Key: 199990381
• Report Number: 1820334-2020-00918
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002081048
• UDI-Public: (01)00827002081048(17)221210(10)10178231
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/10/2022
• Device Model Number: N/A
• Device Lot Number: 10178231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1