MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

Suspect medical device: unknown ultrathane mac-loc drainage catheter.Initial reporter occupation: unknown.Pma/510(k) #: unknown.(b)(4).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 that an unknown patient required the placement of an unknown size of an ultrathane mac-loc drainage catheter for a left sided nephrostomy.It was noted at an unknown date after the procedure that the "sheath material separated from the plastic mac-loc fitting." the suture string was still noted to be in the device.It was reported the patient required the placement of a similar device to continue with treatment.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.It was reported that an unknown ultrathane catheter experienced hub separation.The patient was taken to the er and the device was replaced.Cook became aware of this event upon being notified by hospice & palliative care charlotte region.The patient reportedly experienced no additional adverse effects as a result of this incident, no additional harm was reported.A review of the drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation the complaint device was not returned so a physical examination could not be performed.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook could not review the device history record (dhr) due to lack of lot information from the user facility.Review of the sales records to the user facility over the past three years could not sufficiently narrow down the lot number.Since potential nonconformances or complaints from the complaint device¿s lot could not be confirmed, there is no evidence that nonconforming product exists in house or in the field.A capa was previously opened to address this failure and concluded that the main root cause was manufacturing related.Corrective actions including implementation of a gap gauge and retraining were performed.However, due to an unknown lot number, it is unknown whether or not the complaint device lot was manufactured prior to implementation of the corrective actions.Based on the information provided, no returned product, and results of the investigation, it was concluded that a manufacturing and quality control deficiency potentially contributed to this incident.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9554565
• MDR Text Key: 173889827
• Report Number: 1820334-2020-00061
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention