MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 GO MALE CATHETER WITH SUREGRIP; INTERMITTENT CATHETER

Model Number	53810G
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that upon opening the magic 3 go male intermittent catheter out of the package, the patient was not able to use the catheter due to stem disfigurement.The complainant stated that they were not sure but believed the patient might have still tried to use the catheters and that it hurt, but the complainant could not fully confirm if that was the case or if the patient just decided to not use it at all.The patient had been using the products for more than 90 days.It was mentioned as out of box failure.No medical intervention was reported.
Event or Problem Description
It was reported that upon opening the magic 3 go male intermittent catheter out of the package, the patient was not able to use the catheter due to stem disfigurement.They stated that they were not sure but believed the patient might have still tried to use the catheters and that it hurt, but could not fully confirm if that was the case or if the patient just decided to not use it at all.The patient had been using the products for more than 90 days.It was mentioned as out of box failure.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "inappropriate package design".The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review is not required because labeling could not have prevented the reported issue.The device was not returned.

• Brand Name: MAGIC3 GO MALE CATHETER WITH SUREGRIP
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13258339
• Report Number: 1018233-2022-00030
• Device Sequence Number: 1518864
• Product Code: EZD
• UDI-Device Identifier: 00801741136948
• UDI-Public: (01)00801741136948
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 53810G
• Device Catalogue Number: 53810G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 04/02/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown