MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX SET; JOL CATHETER AND TIP, SUCTION

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the shaft of a wayne pneumothorax set catheter separated from the hub after three days of placement.The device was placed in the left pleura of an unconscious patient.The chest drain valve provided with the set was being used at the time of the event and was connected to the drainage bag.The device was not replaced following hub separation.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: (b)(6) hospital ((b)(6) informed cook on 21nov2021 of an incident involving a wayne pneumothorax (rpn: c-utpt-1400-wayne-112497; lot 14151465) which occurred on (b)(6) 2022.Three days after the catheter was placed, the catheter was found disconnected from the hub.The device was not replaced, and the patient did not require any additional procedures/treatments after the separation occurred.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One wayne pneumothorax set catheter was received in a used condition.The hub was disconnected from the catheter and not returned.Visual examination shows that the flare of the catheter is damaged, possibly occurring when the hub separated from the catheter.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.In addition, cook reviewed the device history record (dhr).The dhr for lot 14151465 and subassembly lot ic13808339 records no relevant non-conformances.A database search for complaints on the final product lot found no additional complaints reported from the field.Cook concluded that the device was manufactured to specification.Cook could confirm that there were no nonconforming devices in house or out in the field.Cook also reviewed product labeling.The product ifu, [c_t_waynemod_rev5] ¿wayne pneumothorax set for seldinger placement provides the following information to the user related to the reported failure mode: instructions for use: ¿confirm catheter placement by valve movement and fluoroscopic or roentgenographic verification.All connections must be secure and airtight.Perform inspections of the catheter and connections regularly.Secure catheter in position at the entry site by using a bio-occlusive dressing or suturing if desired.The catheter and connected drain lines should be secured to the patient.Excessive tension on catheter connections (e.G., in instance of patient movement where the catheter is connected to a vacuum or drainage collection apparatus) may cause catheter/hub separation or accidental catheter dislodgement.To help prevent this from occurring, it is recommended to do one or both of the following: secure the catheter hub to the patient¿s skin by placing tape, suture, or a catheter securement device at the location shown in the illustration below.Form a strain relief loop in the connecting tube, as shown in the illustration below, and secure the loop to the patient¿s skin with tape, suture, or catheter securement device.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible that an external force contributed to the separation of the hub from the catheter, but this cannot be definitively confirmed.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: WAYNE PNEUMOTHORAX SET
• Common Device Name: JOL CATHETER AND TIP, SUCTION
• 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: 12916792
• Report Number: 1820334-2021-02621
• Device Sequence Number: 5207582
• Product Code: JOL
• UDI-Device Identifier: 00827002111820
• UDI-Public: (01)00827002111820(17)230710(10)14151465
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2023
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497
• Device Lot Number: 14151465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 50 KG