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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2019
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 the hub of the wayne pneumothorax set catheter separated prior to being used in a drainage procedure.The physician used the introducer to straighten the pigtail portion of the catheter, when the hub separated from the device.The device was not used in the procedure.No patient contact was made.The physician followed the instructions for use when operating the device.
Event or Problem Description
It was reported in information received on (b)(6) 2019 that the patient has been discharged from the hospital.No additional procedures were required, as the physician used a new device to complete the procedure.The separation was discovered prior to patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is 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 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: a review of the complaint history, device history record, documentation, trends, instructions for use (ifu), quality control, and specifications of the device, as well as a visual inspection, were conducted during the investigation.The complaint device was returned for evaluation.A physical investigation of the returned complaint device confirmed the fitting to be separated from the catheter.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.It should be noted, there have been no (0) non-conformances for this lot.Based on the information provided, inspection of returned product and the results of the investigation, a definitive cause could not be established.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: 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: 8609376
• Report Number: 1820334-2019-01110
• Device Sequence Number: 2293644
• Product Code: JOL
• UDI-Device Identifier: 00827002111820
• UDI-Public: (01)00827002111820(17)201025(10)9355395
• 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,Followup
• Report Date (Section B): 07/24/2019

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: 10/25/2020
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497
• Device Lot Number: 9355395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/14/2019; 06/26/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/11/2019; 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 69