MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; CATHETER, UROLOGICAL

Model Number	510841
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports "catheters are sticking to clear plastic packaging and the hydrophilic coating is creating sharp edges on catheter when removed from packaging and once caused bleeding in urethra.Consumer states nearly every single box he received in his recent shipment as well as 3 months ago had the defect.He said the majority of the catheters in all boxes have the defect.He said there is typically one spot on the clear plastic packaging about 1/8 inch long that the catheter is stuck to.He said he can only assume it is stuck there even before he pops the sterile water packet.He has to pull really hard to get it out and this process is not smooth at all he said.Often catheter will release with a sharp edge he thinks is from the coating/glue.He tries to smooth out the sharp edges with pressure.He can feel the sharp edge to smooth by the stuck part while it is still in the packaging so it doesn't become unsterile prior to use.He started doing this because once he did get cut by using a catheter with this sharp edge and he has a little bit of bleeding he said that lasted for about 2 caths.No medical intervention sought.He states he does not have pain with use of these defected catheters.He caths 6-7 x a day for last 25 yrs for retention from spina bifida.He felt like some are unsafe to use and he did say he has thrown out many from his newest shipment.He tries to wipe off through the clear plastic packaging the "sharp edge" that can be on the catheters to use them." this emdr covers the unknown lot number and quantity of catheters associated with the rough edges.
Additional Manufacturer Narrative
Common device name: catheter, straight.Procode: ezd.Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15320344
• Report Number: 1049092-2022-00333
• Device Sequence Number: 14754026
• Product Code: KOD
• UDI-Device Identifier: 00815947021229
• UDI-Public: 00815947021229
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: K080881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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 Model Number: 510841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male