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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that there was leakage at the three-way connector on a wayne pneumothorax set after placement during a "chest" procedure.At 2:00 p.M.On the date of the event, the procedure was completed and the patient was sent to the observation room.At 6:00 p.M.On the same day, the attending nurse found the connected bag to be empty inside due to the leak.The physician successfully changed the connector to resolve the issue.It was also reported that the physician "took time to change another bed due to the leakage".A catheter hub with an attached stopcock has been returned without the catheter portion.No adverse effects to the patient have been reported.
Event or Problem Description
No information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: h6 - device code: separation problem (4043).Investigation - evaluation: a review of the quality control and instructions for use (ifu) as well as a visual inspection of the returned device was conducted during the investigation.A used fitting and stopcock of a wayne pneumothorax set were returned for evaluation.A functional test of the device was not able to be completed as the catheter portion was not returned.It is possible that the stop cock and fitting leaked at the joint where they are attached to the rest of the device.There is no evidence to suggest that the device was not manufactured to specifications.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the complaint device lot (9582923) revealed no related non-conformances.A database search found this to be the only event associated with the provided complaint lot.Cook also reviewed product labeling.The wayne pneumothorax catheter is supplied with ifu (c_t_waynemod_rev4) which includes the following: "12.The catheter and connected drain lines should be secured to the patient.Excessive tension on the catheter connections (e.G., in instances 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: a.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.B.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" based on the information provided, inspection of the returned product, and the results of our investigation, a definitive root cause could not be established.Cook will continue to monitor for similar complaints.Per the quality engineering 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
• MDR Report Key: 9376889
• Report Number: 1820334-2019-02956
• Device Sequence Number: 16680961
• Product Code: JOL
• UDI-Device Identifier: 00827002111820
• UDI-Public: (01)00827002111820(17)210203(10)9582923
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 02/03/2021
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497
• Device Lot Number: 9582923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 65