MAUDE Adverse Event Report: COOK INC ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.
Event or Problem Description
The international customer reported that the product was packaged with the wire guide inserted backwards, with the hard portion of the guide coming out first rather than the flexible portion.This was noticed through the packaging and the product was never used; accordingly, there was no patient contact and there were no adverse events resulting from this issue.The device is reportedly available for evaluation.
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, documentation, specifications, quality control, manufacturing instructions, trends, and inspection of the returned device was conducted during the investigation.The ultrathane wills-oglesby single lumen percutaneous gastrostomy set was returned in an unopened and sterile condition.During the investigation the package was opened, confirming the supplied wire guide was inserted into the single loop holder backwards.The proximal end was sticking out from the holder at approximately 5.0 cm.The device history record (work order number (b)(4)) was reviewed and confirmed that no nonconformances were recorded.Since the wogs-1200, ultrathane wills-oglesby single lumen percutaneous gastrostomy set is supplied with component parts, the device history record for (b)(4) regarding the complaint device (b)(4) was reviewed and confirmed there were no recorded nonconformances related to the described failure mode.There were two unrelated nonconformances for a wire with damaged coil (device was scrapped), and one for a documentation error (reworked).A review of the work order indicated that the same individual loaded the wire guide in this report as in related report 1820334-2017-02543.Retraining was performed for the operator in question.A complaint search was run for the wogs devices, stiff wire guides, and all devices, looking for similar issues from 01 january 2014 through 20 september 2017.This search showed that these two complaints were the only ones present for wogs sets and thsf wires based on the information provided, the examination of the returned product, and the results of our investigation; the root cause of this complaint is manufacturing-related, as the perforation was caused by the backwards loading of the wire.Retraining was performed for the operator in question, along with a coordinated review of devices produced by the operator after the re-training was performed.No such failures were observed thereafter.This issue was expanded to all wogs sets prepped by the relevant operator.The field action request investigation revealed that this includes 27 lots prepped between 16 april 2016 and 11 september 2017.The conclusion of the investigation was that all of these lots were recalled under far-2017-183.

• Brand Name: ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6834886
• Report Number: 1820334-2017-02544
• Device Sequence Number: 699668
• Product Code: KNT
• UDI-Device Identifier: 00827002052741
• UDI-Public: (01)00827002052741(17)191107(10)7360624
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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-1200
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 01/17/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FAR-2017-183
• Patient Sequence Number: 1