MAUDE Adverse Event Report: COOK INC GUARDIA ACCESS MALLEABLE OBTURATOR; MQF CATHETER, ASSISTED REPRODUCTION

Model Number	G34784
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during incoming quality control inspection at a cook distributor, foreign matter was found in the package of a guardia¿ access malleable obturator.There was no patient involvement.
Additional Manufacturer Narrative
Event description: cook was informed on of an incident involving a guardia access malleable obturator.The customer reported "foreign matter -found during distributors iqc".There was no patient involvement.Investigation ¿ evaluation: a visual inspection of the returned unused device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, and specifications.Visual exam of one returned guardia¿ access malleable obturator noted a black fiber inside the sealed package.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Based on the investigation, this failure mode was attributed to a packaging event.Though the complaint device was determined to be manufactured out of specification, there is sufficient evidence to suggest the rest of the lot and other devices were manufactured to specification.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 new patient or event information since the last report was submitted.

• Brand Name: GUARDIA ACCESS MALLEABLE OBTURATOR
• Common Device Name: MQF CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10288959
• Report Number: 1820334-2020-01315
• Device Sequence Number: 803713
• Product Code: MQF
• UDI-Device Identifier: 00827002347847
• UDI-Public: (01)00827002347847(17)230414(10)13134597
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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
• Operator of Device: No Information
• Device Expiration Date: 04/14/2023
• Device Model Number: G34784
• Device Catalogue Number: K-JET-7002
• Device Lot Number: 13134597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1