MAUDE Adverse Event Report: COOK INC COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

Common name and procode: catheter, hemodialysis, non-implanted, mpb.Occupation: unknown.Pma / 510(k): k161504.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 cook turbo-flo hd hemodialysis catheter was inserted the week prior.It is unknown how the swivel piece became disengaged from the hub.As reported by the user, "it is meant to be sutured and secured while we swivel the line inside it.It is difficult to separate both pieces.It does not appear to be broken." additional patient and event details have been requested.At the time, no additional information is available to report.

Event Description

It was reported in additional information on 19jun2019 that the swivel piece had separated from the main hub.The user did not see any broken or damaged areas inside the swivel piece nor on the outside of the hub.The patient was gently turned with continuous hemodialysis(hd) running and the hd line fell out, leaving the swivel piece still sutured to the patient.The line remained on the bed and the patient was bleeding.The area was cleansed, the swivel piece taken off and hemodialysis was stopped.A new hd line had to be inserted into a new site.The patient had been heavily sedated during the entire week the device was inserted, so they could not have "pulled on or messed with it." the catheter was not pulled hard during the turn, as the patient was still receiving continuous hemodialysis.It was reported that the catheter, "just slid out." the device is not available for return, as it was discarded by the facility.

Manufacturer Narrative

H6 - patient code: no code available (3191) - patient required an additional procedure to replace the device.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 new event description information to report at this time.

Manufacturer Narrative

Investigation/evaluation: a review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be completed.A previous complaint on a similar product, reported in mfg.Report reference #: 1820334-2017-00067, concluded that it is possible that the wing separated from the manifold due to rough handling of the product, either pushing or pulling of the catheter.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The exact lot number of the device is unknown, however, review of the sales records to the user facility over the past three years narrowed down the lot number to one of four: 7531610, 7550200, 8757365 or 9073246.A review of the device history record for these lots found no nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints reported for these lot numbers.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description: ".The catheter also contains a swivel fitting, which allows free catheter rotation without removal of securement sutures." instructions for use: "15.¿the winged hub can now be sutured into place.If the catheter is not introduced to its full lengths, additional suture should be carefully placed around the catheter and affixed to the skin at the entry site.This will help prevent backward or forward catheter movement." based on the information provided, no returned product and the results of our investigation, a definitive root cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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: COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8641053
• MDR Text Key: 146371638
• Report Number: 1820334-2019-01307
• Device Sequence Number: 1
• Product Code: MPB
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: C-HDCSYJ-1201J-RSC-IHI-CCT-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 06/19/2019; 07/31/2019
• Supplement Dates FDA Received: 07/17/2019; 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention