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

Model Number	44314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bleeding is one of the lower urinary tract symptoms seen in patients with benign prostatic hyperplasia.The patient was diagnosed with bph which can cause uncomfortable urinary symptoms, such as blocking the flow of urine out of the bladder.It can also cause bladder, urinary tract or kidney problems and sign of blood in urine which is well known by both the patients and health care professionals.In this case, the patient was diagnosed with lower urinary tract symptoms and bph, and this may have contributed to the bleeding.The investigation of returned devices and review of the production batch records did not provide any conclusion for root cause.No earlier complaints registered for this lot.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
According to the patient, ever since the manufacturer changed the layout of lofric origo delivery box known as customer package from dark blue to light blue, the amount of saline solution has been inconsistent.The user states when he removes the activated lofric origo urinary catheter out of the package, sometimes it drips and other times it doesn't- suggesting this is one indication the solution amount varies.The patient explains he can distinguish the catheters that aren't sufficiently lubricated only on catheterization as they cannot be inserted smoothly, and the catheterization is uncomfortable.On (b)(6) 2021 the patient had a traumatic catheterization which resulted in an urgent visit to his urologist.He had moderate to large bleeding with blood clots.The urologist irrigated the patient's bladder, placed and indwelling and prescribed 10 days of cipro/antibiotic.On (b)(6) 2021 the patient had his foley catheter removed and resuming ic using the lofric origo supply per his urologist's suggestion.

• Brand Name: LOFRIC ORIGO
• Common Device Name: CATHETER STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; molndal, SE-43 121; SW SE-43121
• MDR Report Key: 12413329
• Report Number: 3009632672-2021-00001
• Device Sequence Number: 11638714
• Product Code: EZD
• UDI-Device Identifier: 07392532158308
• UDI-Public: 07392532158308
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/29/2022
• Device Model Number: 44314
• Device Catalogue Number: 4431440
• Device Lot Number: 457907, 447716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/02/2021
• 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: 77 YR