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

Model Number	N/A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported by the international customer that, when handling the catheter contained in the wayne pneumothorax set, the joints created between the different components were loosened too easily.The circumstances surrounding the usage and handling of the device are not known.The product is reportedly not available for return.No further information was provided by the customer.
Additional Manufacturer Narrative
Corrected information: report source.Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications, and quality control data was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.However, a photo was provided and reviewed.The photo appears to indicate a loose or split fitting with the device.If the device is returned for evaluation, a thorough analysis and determination will be done and the record will be updated at that time.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A thorough review of the device history record did not observe any non-conformances that may have contributed to this incident associated with the complaint.There were two other reported complaints for this lot number from the same facility.The device is shipped with the instructions for use that states the proper warnings and precautions.Specifically; ¿device is not recommended for large fluid accumulation or hemothorax.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 may cause catheter/hub separation or accidental catheter dislodgement." based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6877252
• Report Number: 1820334-2017-02939
• Device Sequence Number: 11058226
• Product Code: JOL
• UDI-Device Identifier: 00827002111820
• UDI-Public: (01)00827002111820(17)181209(10)7602375
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 12/20/2017
• Patient Sequence Number: 1