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

Model Number	40012
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used product was not returned and no unused products from the same lot were returned for investigation.No photos were sent.No deviations identified in manufacturing records for the lot.Without the benefit of examination and testing, wellspect healthcare 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.
Event or Problem Description
Reported from (b)(6).According to the reporter (a pharmacist, who had received information from an orthopedic) a patient using a catheter experienced it broke during withdrawal.The remaining piece was removed in hospital care.

• Brand Name: LOFRIC
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; moelndal, SE-43 121; SW SE-43121
• MDR Report Key: 8715767
• Report Number: 3009632672-2019-00007
• Device Sequence Number: 1860185
• Product Code: EZD
• UDI-Device Identifier: 07392532131851
• UDI-Public: 07392532131851
• Combination Product (Y/N): N
• PMA/510(K) Number: K113424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: Lay User/Patient
• Device Expiration Date: 01/30/2022
• Device Model Number: 40012
• Device Catalogue Number: 40012
• Device Lot Number: 18214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/20/2019
• 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: Hospitalization; Required Intervention