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

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: unknown.Pma/510(k) #: exempt.Investigation ¿ evaluation: it was reported to cook that a wayne pneumothorax set, c-utpt-1400-wayne-imh, from lot # 13173794, had foreign particles inside the package.This incident was reported by (b)(6), in (b)(6), on (b)(6) 2020.The complaint was found at a distribution center, so no patient contact was made.No adverse effects were reported.A review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, photos of the device were provided and foreign particles were confirmed to be within the sealed packaging.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) found that the risks of this device were acceptable when weighed against the benefits.The device history record (dhr) for lot # 13173794 revealed no reported nonconformances that could have contributed to the reported failure mode.A database search revealed no other complaints have been associated with this device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.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.¿ from the information provided upon review of the dmr, dhr, dhf, ifu, and provided imaging, cook can confirm that the device was manufactured out of specification, but cook did not find evidence of additional nonconforming devices in house or out in the field.Based on the information provided, examination of product photos and the results of our investigation, a definitive root cause can be traced to a quality control deficiency.Per the quality engineering risk assessment no further action is required.The appropriate personnel will be notified, and cook will continue to monitor for similar complaints.
Event or Problem Description
It was reported by the customer that during shipping inspection of the product, particles were found inside the device primary packaging.The device did not make patient contact.

• 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: 10431136
• Report Number: 1820334-2020-01527
• Device Sequence Number: 1712194
• Product Code: JOL
• UDI-Device Identifier: 00827002565333
• UDI-Public: (01)00827002565333(17)220330(10)13173794
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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: No Information
• Device Expiration Date: 03/30/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-IMH
• Device Lot Number: 13173794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1