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

Model Number	G11182
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) number: 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 a wayne pneumothorax set was separated at the joint.This separation was detected prior to patient contact.No adverse effects to the patient were reported.Additional information related to the event has been requested, but is unavailable at this time.
Event or Problem Description
No new event information to report.
Additional Manufacturer Narrative
Investigation/evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, and quality control data.One device was returned to manufacturer for investigation.The returned packaging confirms lot number 9207548.Visual examination noted the device was returned with the fitting separated from the tubing.The flare on the tubing is slightly slanted.A review of the device history for lot number lot 9207549 showed no related non-conformances.A review of complaint history revealed there have been no other complaints associated with the complaint device lot number 9207549.The instructions for use (ifu) provides the following information in consideration of the reported failure mode: how supplied: 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.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.A physical inspection of the complaint device was performed, and it was confirmed that the fitting is separated from the hub.The slightly slanted flare on the tubing indicates that the tubing may have been pulled from the fitting.Cook has concluded that it is likely unintended use error caused or contributed to this event.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and cook will continue to monitor for similar complaints.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.

• 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: 8325153
• Report Number: 1820334-2019-00410
• Device Sequence Number: 1789457
• Product Code: JOL
• UDI-Device Identifier: 00827002111820
• UDI-Public: (01)00827002111820(17)200826(10)9207549
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 08/26/2020
• Device Model Number: G11182
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497
• Device Lot Number: 9207549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/28/2019
• Patient Sequence Number: 1