MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Phone: (b)(6).Occupation: unknown.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 a female patient required an ultrathane mac-loc locking loop multipurpose drainage catheter for post operative abdominal drainage.The catheter was attached to a drainage bag and was secured with adhesive tape.Three hours after placement, the catheter dislodged when the patient got out of bed.The device was replaced with a similar device.No other adverse effects were reported for this incident.

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 unknown, unavailable, or unchanged.Investigation ¿ evaluation: it was reported by junzhong sun of the second affiliated hospital of anhui medical university, china, that an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot: 13631139) dislodged from a patient.On 01jul2021 at 13:10, during an abdominal puncture procedure, the catheter was placed in a 65-year-old female patient for postoperative abdominal drainage.A drainage bag was attached to the catheter and the catheter was secured with adhesive tape.¿the puncture site was fixed by application¿.About three hours later, at 16:20, the patient got out of bed to go to the toilet when the catheter dislodged.The doctor was notified, and the catheter was subsequently replaced.No other adverse effects were reported for this event.Reviews of documentation including the complaint history, device history record (dhr), quality control, and instructions for use (ifu), 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.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the dhrs for the reported complaint device lot and the related subassembly lots revealed no related non-conformances.A database search identified three other events reported for "catheter separated during removal", and "patient inadvertently pulled catheter out".These complaints were opened having the same date and were reported by the same facility.The reported lot underwent proximal assembly on 17dec2020 and was manufactured using an asset id that passed calibration on 12oct2020 and 15feb2021.There is objective evidence the dhr was executed, and there is no evidence of manufacturing deficiency.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use (ifu) t_multi_rev5 supplied with the suspect lot were reviewed for the information related to reported failure mode.Per the ifu: ¿upon removal from package, inspect the product to ensure no damage has occurred¿.It is unknown if the device was examined for possible damage prior to use.Based on the available information, no device return, and the results of the investigation, the cause for this event cannot be traced to the device.It was reported that the failure was discovered when the patient was ambulating to the toilet.It was also reported that the catheter was attached to a drainage bag and secured with tape.The volume in the drainage bag is unknown.It is possible that during patient movement the drainage line became entangled with the surroundings which could have led to inadvertent pulling on the device.This tension could have been compounded if the drainage bag was full/heavy.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 12788503
• MDR Text Key: 280601631
• Report Number: 1820334-2021-02474
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)231215(10)13631139
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

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 Expiration Date: 12/15/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 13631139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female