MAUDE Adverse Event Report: COOK INC POLYETHYLENE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number G00174

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown healthcare professional.Pma/510(k) number: pre-amendment.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, a hair was found inside the package of a polyethylene angiographic catheter.The device did not make patient contact.

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, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, documentation, manufacturer¿s instructions, and quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device revealed a hair-like fiber present inside the packaging.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that the failure mode can be attributed to the manufacturing and packaging of the device.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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.

• Brand Name: POLYETHYLENE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8842695
• MDR Text Key: 152950421
• Report Number: 1820334-2019-01872
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002001749
• UDI-Public: (01)00827002001749(17)210605(10)8852653
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: G00174
• Device Catalogue Number: P6.7-38-100-P-4S-GPC
• Device Lot Number: 8852653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1