MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB LOFRIC SENSE; CATHETER, STRAIGHT

Model Number	41612
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The examination of the six returned catheters showed that the catheters got stuck to the packaging.The user is concerned that the device is linked with an infection.The manufacturer has not been able to establish any relation between the device and the reported harm (infection), but it could not be excluded that there is a relationship between the device and the infection.It is unknown whether the user used the catheter or not.The manufacturer has made unsuccessful attempts to receive more information regarding this incident and the severity of infection, but the user does not want to provide any additional information.No actions are considered to be required.This type of deficiency is considered to be easy to detect prior to use of the device.Sterilization dose has been substantiated by dose auditing studies and bioburden levels are routinely monitored and have been within specification.Should additional information be received, a follow-up report will be filed.
Event or Problem Description
According to the reporter, the catheter was stuck to the foil in the package and upon removal from the package, the foil was physically removed.The user is concerned that this could be linked with an infection, but does not want to provide any further information regarding this incident.It is not known whether the use used the catheter or not.

• Brand Name: LOFRIC SENSE
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; mölndal, sweden SE-43 121; SW SE-43121
• MDR Report Key: 7132814
• Report Number: 3009632672-2017-00007
• Device Sequence Number: 19160158
• Product Code: EZD
• UDI-Device Identifier: 07392532086366
• UDI-Public: 07392532086366
• Combination Product (Y/N): N
• PMA/510(K) Number: K123751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

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 Model Number: 41612
• Device Catalogue Number: 41612
• Device Lot Number: 406116
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other