MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 INTERMITTENT CATHETER

Model Number	51612
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2021
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.The device was not returned.
Event or Problem Description
It was reported that the water packet should be packed on the paper side, and not the plastic film side.Also, the customer found that most of the catheters were wrongly packed in the previous samples.Both the rochester and bard were inconsistent in the orientation and the layering of the water packet.With the packet adjacent to the clear plastic film side, followed the instructions would not result in adequate lubrication of the catheter.Also, the packet was often aligned, so the water squirts toward the funnel, but not at the tip.The neck of the plastic film in the rochester brand was too wide, allowing the packet to slide up toward the funnel.The hydrophilic version, avoids the build up of lubricant with frequent catheterization.Sometimes, the coating seems barely adequate.Per follow-up via phone on 12jan2021, the customer added the water packet to lubricate the catheter completely because of the way it was positioned in the package.

• Brand Name: MAGIC3 INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11263576
• Report Number: 1018233-2021-00219
• Device Sequence Number: 3384205
• Product Code: KOD
• UDI-Device Identifier: 00801741068232
• UDI-Public: (01)00801741068232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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: 51612
• Device Catalogue Number: 51612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2021
• Initial Report FDA Received Date: 02/01/2021
• 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