MAUDE Adverse Event Report: COOK INC ONE-STEP SUPRAPUBIC INTRODUCER; KGZ ACCESSORIES, CATHETER

Catalog Number	SANT-22-20-PLV
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510k #: exempt.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 is reported while examining devices at the distribution center, a hair like foreign matter was found within the sealed package of a one-step suprapubic introducer.The device was never shipped to a user facility.The device did not come into contact with any patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: reviews of the complaint history, device history record, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one unopened step suprapubic introducer was returned for investigation.The visual examination also confirmed that the sealed, unopened package contained a hair-like fiber.Additionally, a document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the specifications and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ".Do not use the product if there is a doubt as to whether the product is sterile.Upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to manufacturing and quality control.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.
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: ONE-STEP SUPRAPUBIC INTRODUCER
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8698382
• Report Number: 1820334-2019-01400
• Device Sequence Number: 2473157
• Product Code: KGZ
• UDI-Device Identifier: 00827002266667
• UDI-Public: (01)00827002266667(17)201023(10)8313777
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 07/23/2019

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: Health Professional
• Device Expiration Date: 10/23/2020
• Device Catalogue Number: SANT-22-20-PLV
• Device Lot Number: 8313777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1