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

Catalog Number SANT-22-20-PLV

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

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: cook district manager.Pma/510k # exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

A cook medical sales representative ordered a one-step suprapubic introducer as a sample for a customer.Upon opening the box the device was delivered in, the sales rep discovered that the packaging of the one-step suprapubic introducer had holes in it.There was no patient involvement.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, quality control data, and specifications.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.A review of the device history record found no non-conformances related to the reported failure mode.Because 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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.A visual examination confirmed the device was returned in a sealed package.The silicone tubing covering the needle had been cut.The trocar tip penetrated through the side wall of the tubing and cut the clear poly on the package compromising the sterility of the device.A review of the device history record shows no nonconformance's were present for this lot prior to distribution.A review of the device master record shows that each individual product is inspected for holes prior to shipment.Therefore there is no evidence to suggest nonconforming product was released.The cause for this event has been attributed to an insufficient product design leading to a punctured pouch during shipping and handling of the product prior to opening.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Most probable cause, package was damaged during shipment or product storage.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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 Description

There is no new patient or event information to report.

• Brand Name: ONE-STEP SUPRAPUBIC INTRODUCER
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9082754
• MDR Text Key: 159146642
• Report Number: 1820334-2019-02354
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002266667
• UDI-Public: (01)00827002266667(17)220801(10)9921401
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: SANT-22-20-PLV
• Device Lot Number: 9921401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1