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

Catalog Number	C-CASP-A-FORD
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: 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 during incoming inspection foreign matter, black particle, was found inside the primary packaging of a sealed simple pneumothorax aspiration accessory set.As reported, this device issue was discovered during inspection; therefore, it did not make contact with the user or patient.
Additional Manufacturer Narrative
Correction age or date of birth, sex, weight, ethnicity.Device evaluation: the device was not returned for evaluation, however, a photo of the device was sent by the distributor.Visual inspection has confirmed a black particle within the sterile packaging.Investigation: a document-based investigation reviewed the following: instructions for use, device history records, complaint history ,quality control specifications and manufacturing instructions.There is no evidence to suggest the finished product was not made to specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no related nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Risk assessment determined that risk controls are in place to mitigate this failure mode and that additional risk reduction activities are not necessary at this time.The appropriate personnel were notified, and we will continue to monitor for similar complaints.Conclusion: based on the information provided and the results of our investigation, a definitive conclusion was able to be made.This failure is likely to be manufacturing-related, specifically due to operator error.Foreign matter was introduced into the device packaging at some point during manufacturing, and it was not rejected per the appropriate quality control procedures.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: SIMPLE PNEUMOTHORAX ASPIRATION ACCESSORY SET
• Common Device Name: JOL CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7899142
• Report Number: 1820334-2018-02756
• Device Sequence Number: 1433877
• Product Code: JOL
• UDI-Device Identifier: 00827002052970
• UDI-Public: (01)00827002052970(17)200312(10)8683582
• 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,Followup
• Report Date (Section B): 12/06/2018

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 Expiration Date: 03/12/2020
• Device Catalogue Number: C-CASP-A-FORD
• Device Lot Number: 8683582
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1