MAUDE Adverse Event Report: COOK INC WILLIAMS CYSTOSCOPIC INJECTION NEEDLE; FBK ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Catalog Number 090001

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation: purchasing.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, there was a small hair within the package of an williams cystoscopic injection needle.The issue was discovered when the device was opened, but before it was taken to the sterile field.A new device was opened for use during the procedure.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

H3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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

Device was returned 20jan2022.Packaging of the returned device has a different lot number than what was reported in our initial report.Lot number information has been updated.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, there was a small hair within the package of a williams cystoscopic injection needle.The issue was discovered when the device was opened, but before it was taken to the sterile field.A new device was opened for use during the procedure.No adverse events have been reported as a result of the alleged malfunction.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was returned in open packaging.The reported failure mode of a hair inside the package was confirmed.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿do not use the product if there is doubt as to whether the product is sterile.¿ based on the available information, cook has concluded that the cause of this event is manufacturing related.As the personnel responsible for the inspection of this device is no longer employed by cook, retraining was not completed.Cook will continue monitoring of similar complaints and has 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 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: WILLIAMS CYSTOSCOPIC INJECTION NEEDLE
• Type of Device: FBK ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13250920
• MDR Text Key: 283768189
• Report Number: 1820334-2022-00051
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 10827002142203
• UDI-Public: (01)10827002142203(17)240924(10)14234315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2022

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
• Device Catalogue Number: 090001
• Device Lot Number: 14069128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 01/20/2022; 02/17/2022
• Supplement Dates FDA Received: 02/11/2022; 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1