MAUDE Adverse Event Report: COOK INC ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Occupation: (b)(4).Pma/510(k) #: exempt.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 an unknown patient required an ultrathane intro-tip design curved universal drainage catheter for a chest tube placement procedure.After placement, the operator reported the "drainage catheter came loose from the connector." on the following day, the device was removed and a second device of the same lot was placed.This caused the patient to be hospitalized an extra day.However, the second device separated during the procedure.The device was removed and a third device was used to successfully complete the procedure.No other adverse effects were reported.The first device is captured under medwatch report # (b)(4).The second device is captured under patient identifier (b)(6) (this report).

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.Hca trident health system in the united states informed cook that the hub on an ultrathane intro-tip design curved universal drainage catheter separated during placement.The failure occurred during a replacement procedure.The complaint device was removed and another device from the same lot was placed to successfully complete the procedure.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There are adequate inspections in place to detect this failure.The device history record (dhr) for the complaint lot was reviewed.There are no related nonconformances on this lot.There is one additional complaint on the complaint lot for the same reported failure.The same customer reported that a previous device was placed in the patient and separated after placement (medwatch report #1820334-2020-02184).The device was returned for evaluation, and cook did not confirm that the device was manufactured out of specification.There is no evidence of manufacturing deficiency.There is no evidence of nonconforming material in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: ¿patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.¿ there is no evidence of manufacturing deficiency.Based on the information provided, no inspection of returned product and the results of the investigation, the cause of this event is component failure.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.

• Brand Name: ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11021347
• MDR Text Key: 223797296
• Report Number: 1820334-2020-02319
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002109599
• UDI-Public: (01)00827002109599(17)230224(10)13006135
• 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,Followup
• Report Date: 04/28/2021

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: 02/24/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-3S-UCD-HC
• Device Lot Number: 13006135
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/25/2021; 04/13/2021
• Supplement Dates FDA Received: 03/03/2021; 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1