MAUDE Adverse Event Report: COOK INC; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional concomitant medical products: ultrathane wills-oglesby single lumen mallinckrodt inst modification gastrostomy set.510k status: preamendment.(b)(4).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
The customer reported that a foreign object was discovered inside of the packaging of the ultrathane wills-oglesby single lumen mallinckrodt inst modification gastrostomy set.The object reportedly punctured the packaging as well.The device did not make contact with any patient; according, no patient adverse events resulted from the product problem.The device has been received for evaluation, but the investigation is still pending as of the date of this report.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, specifications, and a visual inspection/dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a foreign metal clip in the sealed bag, which is not a component that should be packaged with the device.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 relevant manufacturing documents was performed.The device was visually inspected by quality control and no notable gaps in production or processing controls were noted.A review of the device history record showed no nonconforming events.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause is manufacturing related.Retraining was requested and performed for the relevant departments.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7313565
• Report Number: 1820334-2018-00435
• Device Sequence Number: 16513022
• Product Code: KNT
• UDI-Device Identifier: 00827002084179
• UDI-Public: (01)00827002084179(17)200906(10)8160201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: WOGS-1400-MKDT-A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1