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

Catalog Number	WOGS-1400-MKDT-A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: ultrathane wills-oglesby single lumen mallinckrodt inst modification gastrostomy set.(b)(4).Pma/510(k) #: preamendment.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 an ultrathane wills-oglesby single lumen mallinckrodt inst modification gastrostomy set was returned to the distributor due to a hair being found inside the package two weeks prior by quality control.The reported foreign matter was discovered before use; therefore, no patient contact.
Additional Manufacturer Narrative
Corrected data: operator of device:quality control-distributor.Investigation ¿ evaluation: a review of the complaint history, device history record, quality control and a visual inspection/dimensional verification of the returned device were conducted during the investigation.The visual inspection of the unopened returned device confirmed the presence of foreign matter enclosed within the outer pouch.The device is out of specification per quality control documents - foreign matter.Additionally, a document based investigation evaluation was performed.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.Therefore, there is no evidence to suggest all items in the lot or similar devices in house or in the field are non-conforming/defective.Based on the information provided, the examination of the returned product, and the results of our investigation, the actual root cause was found to be manufacturing related.We have notified the appropriate personnel and will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
No new event description information to report at this time.

• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7486098
• Report Number: 1820334-2018-01201
• Device Sequence Number: 13966400
• Product Code: KNT
• UDI-Device Identifier: 00827002084179
• UDI-Public: (01)00827002084179(17)210126(10)8411128
• 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,Followup
• Report Date (Section B): 08/06/2018

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: Other
• Device Catalogue Number: WOGS-1400-MKDT-A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1