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

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, quality control, and a photographic inspection of the device were conducted during the investigation.The photographic inspection of the complaint device confirmed the reported condition.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the complaint product, and the results of our investigation, the root cause was determined to be manufacturing related.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The international customer reported that, during a pre-use inspection of the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter, an unidentified particle was discovered within the primary package of the device.The device was not used on a patient; accordingly, no patient adverse events resulted from the product issue.The device is reportedly unavailable for return and evaluation.

• 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: 7318771
• Report Number: 1820334-2018-00433
• Device Sequence Number: 10800918
• Product Code: JOL
• UDI-Device Identifier: 00827002565333
• UDI-Public: (01)00827002565333(17)190707(10)8140633
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

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-IMH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1