MAUDE Adverse Event Report: CURE MEDICAL LLC CURE MEDICAL CATHETER INSERTION KIT; CATHETER CARE TRAY

Model Number	K1
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said she had used the catheter from another manufacturer and the k1 kits for over four years without a problem.She reported that her doctor thought the infection may be related to her medical supplies and catheterization.She noticed in (b)(6) 2021 that a few units of k1 kits had some "sand like" debris like "grey silver specks" when she opened the package that fell out and some discoloration of the gloves.She did not use the kits after discovering those units and prefers to not use the k1 kits again.The patient had the suspect gloves to return but decided not to return them and discarded the problem units.The patient also provided another lot number, 19307801, but was unable to confirm the lot number of the k1 kit with the gloves she was using at the time of the infection and if it was from this lot.
Event or Problem Description
Intermittent catheter patient (user) said she got a urinary tract infection (uti) and has been sick for six months concurrent with use of a catheter from another manufacturer but thinks it is from using gloves from a cure medical brand catheter kit (gloves, bzk wipe, collection bag, mattress protector, lubricating jelly).She notices the gloves have had a black substance on or in the gloves - more than dust - looks like it was wet, dried, and then flaked off.The black substance is embedded in the rim of the glove.The patient said the bacteria is rare according to her doctor who cannot tell where it is coming from but knows it is catheter related.During follow-up, the patient said was prescribed a dose of bactrim, then a second and third dose, but the infection was not resolved.She was then placed on bactrim as a maintenance antibiotic that resolved the infection and feels fine now.

• Brand Name: CURE MEDICAL CATHETER INSERTION KIT
• Common Device Name: CATHETER CARE TRAY
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 11711064
• Report Number: 3005471919-2021-00040
• Device Sequence Number: 19587776
• Product Code: OHR
• UDI-Device Identifier: 00815947020468
• UDI-Public: (01)00815947020468(17)221228(10)19306401(241)K1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/28/2022
• Device Model Number: K1
• Device Catalogue Number: K1
• Device Lot Number: 19306401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/22/2021
• 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