MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, MALE; MAGIC 3 CATHETERS

Model Number	53614GS
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 there was not enough lubrication on some of the catheters.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿viscosity too high/low¿.A potential root cause for this failure could be ¿operator error or mechanical failure¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "prior to opening the sealed catheter pouch, apply pressure to the foil packet to release the water.Ensure all water is released from the foil packet".
Event or Problem Description
It was reported that there was not enough lubrication on some of the catheters.No medical intervention was reported.

• Brand Name: MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, MALE
• Common Device Name: MAGIC 3 CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8612460
• Report Number: 1018233-2019-02569
• Device Sequence Number: 11292107
• Product Code: OHR
• UDI-Device Identifier: 00801741072659
• UDI-Public: (01)00801741072659
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 53614GS
• Device Catalogue Number: 53614GS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1