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

Model Number	40014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Examination of three unused, returned samples from the same catheter box and lot (manufactured 2016) showed deficiency matching the description by the reporter.Possible caused during packaging.The packaging machinery was replaced in 2018.
Event or Problem Description
Event occured in (b)(6).According to the reporter, the nurse noted that blood came out when the nurse removed the urinary catheter from the patient after bladder emptying.At that point, the nurse saw that the catheter end was sharp and that there was a piece of the catheter tip missing.According to the manufacturer's understanding, from the description provided by the reporter, the missing part, i.E.The catheter tip, was left in the catheter packaging and not inserted into the patient.The bleeding was said having lasted 6 hours after catheterisation, but did not re-occur after that.No negative outcome has been observed following the event.

• 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, sweden SE-43 121; SW SE-43121
• MDR Report Key: 8296047
• Report Number: 3009632672-2019-00002
• Device Sequence Number: 16642185
• Product Code: EZD
• UDI-Device Identifier: 07392532131844
• UDI-Public: 07392532131844
• 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
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: 40014
• Device Catalogue Number: 40014
• Device Lot Number: 181630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/01/2019
• 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: Other
• Patient Age: 80 YR
• Patient Weight: 70