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

Model Number	53614GS
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 10 of the catheters had burst packets that had no solution and the patient did not use them.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿no water¿.A potential root cause for this failure mode could be ¿incorrect process parameters¿.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: "1.Wash your hands thoroughly with soap and water.2.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.3.Wet the catheter by holding the package with the printed side up and tip the package end-to-end three to six times to wet catheter.This movement is required so that the water transfers back and forth over the catheter to fully wet the hydrophilic coating." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that 10 of the catheters had burst packets that had no solution and the patient did not use them.No medical intervention was reported.

• Brand Name: MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, MALE
• Common Device Name: MAGIC 3CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8722711
• Report Number: 1018233-2019-03265
• Device Sequence Number: 2573301
• 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): 07/16/2019

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: 05/30/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1