MAUDE Adverse Event Report: COOK INC ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G18154

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the roadrunner the firm hydrophilic wire guide was inspected at the time of receipt and a hair was observed inside of the device package.This device was not used on a patient.

Manufacturer Narrative

Investigation/evaluation: the investigation performed for this complaint report included a review of complaint history, the device history record, and specifications.A visual inspection of the returned device was also conducted during the investigation.One unopened package was received and labeled with lot number 8464232.Visual observation of the sealed package confirms a hair like fiber loose inside the sealed package.The device history record was reviewed and noted one non-conformance during the manufacturing process.One device with foreign matter embedded in packaging material was identified and the item was reworked.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 8464232.Based on the evidence presented by the sample, the cause of this complaint is likely manufacturing related.Additional measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• Brand Name: ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7346180
• MDR Text Key: 103162388
• Report Number: 1820334-2018-00477
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002181540
• UDI-Public: (01)00827002181540(17)201221(10)8464232
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

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
• Device Operator: Other
• Device Model Number: G18154
• Device Catalogue Number: RPC-035145
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/01/2018
• Patient Sequence Number: 1