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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: unknown.Pma/510(k) #: exempt.Investigation - evaluation: interfreight n.Y.Informed cook on 18jun2020 of an incident involving a wayne pneumothorax set (rpn: c-utpt-1400-wayne-imh) from lot # 13071097.A foreign particle was found inside the primary packaging.The complaint was found at a distribution center, so no patient contact was made and no adverse events to the patient were reported.A review of the complaint history, device history record (dhr), instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, the user facility provided photos of the device in its packaging to cook for evaluation.From the supplied photos, a foreign particle can be confirmed to be within the sealed packaging.These photos suggest that this device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) found that this product is both safe and effective for its intended use.A review of the device history record (dhr) for the reported complaint device lot (13071097) revealed one relevant non-conformance for foreign matter, in which two devices were reworked.A database search did not find any other events associated with the reported device lot.As all nonconforming products were reworked, there is a 100% inspection for the reported nonconformance, and no additional complaints from the field have been received for this lot.At this time, cook did not conclude that nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The product ifu, ¿wayne pneumothorax set for trocar placement,¿ 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.¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause was traced to a deficiency in manufacturing/quality control.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that during inspection, a foreign particle was noticed in the primary packaging of a wayne pneumothorax set.No patient contact was made.

• 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: 10220927
• Report Number: 1820334-2020-01242
• Device Sequence Number: 19500259
• Product Code: JOL
• UDI-Device Identifier: 00827002565333
• UDI-Public: (01)00827002565333(17)220223(10)13071097
• Combination Product (Y/N): N
• 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): 07/01/2020

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: 02/23/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-IMH
• Device Lot Number: 13071097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1