MAUDE Adverse Event Report: OASIS MEDIKAL A/S HI-SLIP PLUS; CATHETER, STRAIGHT

Model Number	HS.PM4014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although encouraged by manufacturer, the used product or unused samples were not returned for investigation.Without the benefit of examination and testing, oasis medikal is precluded from commenting on the condition of the device or the cause of occurrence.Should the device or additional information be received, a follow up report will be filed.No previous complaints or deviations reported for the lot.
Event or Problem Description
According to the reporter, the customer was using a catheter with unpolished eyelettes which caused tearing and "pulled a chunk of skin" out of the urethra.The customer was then hospitalized due to bleeding, fever and sepsis and was treated with antibiotics.
Additional Manufacturer Narrative
A returned, unused catheter from the same lot was evaluated and and water retention test was performed.No deficiencies were found.

• Brand Name: HI-SLIP PLUS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): OASIS MEDIKAL A/S; fatih mah. 3105. cad. no:8; kazan/ankara, 06980 ; TU 06980
• MDR Report Key: 6689293
• Report Number: 3006553489-2017-00001
• Device Sequence Number: 16154848
• Product Code: EZD
• UDI-Device Identifier: 08697749684725
• UDI-Public: 08697749684725
• Combination Product (Y/N): N
• PMA/510(K) Number: K062444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/01/2019
• Device Model Number: HS.PM4014
• Device Catalogue Number: HS.PM4014
• Device Lot Number: 16264
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 01/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other