MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number 133624

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: postal code: postal code: (b)(6).Pma/510k #: 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

It was reported, the package for a filiform double pigtail ureteral stent set was opened, and a hair was discovered inside.There was no patient contact.No adverse effects have been reported.Additional information has been requested.At this time, no other information is known.A follow up report will be submitted if additional details are received.

Manufacturer Narrative

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

It was reported in our initial report, that the package for a filiform double pigtail ureteral stent set was opened, when and a hair was discovered inside.It was reported that the package was unopened.The date of event was also known and inadvertently not reported.

Event Description

No new patient or event information since that last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.On 26feb2020, cook was informed of an event involving a filiform double pigtail ureteral stent set.Prior to opening the package, a hair was noticed inside the device pouch.The device did not contact the patient.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, specifications, and quality control data.The complainant returned one unopened package containing a filliform double pigtail ureteral stent set for investigation.Visual examination of the sealed package confirmed a dark hair-like fiber approximately 2cm trapped inside the packaging tray.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.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 visual examination of the returned device showed a hair-like fiber contained within the packaging tray.Due to the individual nature of inspecting product packaging for foreign matter during manufacturing, one nonconformance does not indicate additional non conformances in the lot.Additionally, there have been no other complaints filed for this lot.Therefore, there is no evidence to suggest that nonconforming product are in the field; however, this lot will continue to be monitored.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Based on the evidence presented by the sample, this event has been contributed to a packaging event.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9799433
• MDR Text Key: 183350411
• Report Number: 1820334-2020-00560
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151458
• UDI-Public: (01)10827002151458(17)221205(10)10193544
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2022
• Device Catalogue Number: 133624
• Device Lot Number: 10193544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/03/2020; 03/26/2020
• Supplement Dates FDA Received: 03/12/2020; 03/30/2020
• Patient Sequence Number: 1