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

Model Number	50812G
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
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 the 12fr magic3 go catheters were larger in diameter than the cure 12fr catheters.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.Visual inspection noted 22 unopened magic 3 go intermittent catheters were received.Visual evaluation noted no obvious defects.Samples were tested.The outer diameters of the catheters measured to be 0.1535", 0.1530", 0.1490", 0.1510", and 0.1435" which was found to be out of specification (0.157" +/- 0.013").Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be operator error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.Corrections: d, h.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the 12fr magic3 go catheters were larger in diameter than the cure 12fr catheters.

• Brand Name: MAGIC3 GO MALE COUDE CATHETER WITH SUREGRIP
• Common Device Name: MALE COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10674069
• Report Number: 1018233-2020-20120
• Device Sequence Number: 16864138
• Product Code: EZD
• UDI-Device Identifier: 00801741137013
• UDI-Public: (01)00801741137013
• 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: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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 Expiration Date: 12/28/2022
• Device Model Number: 50812G
• Device Catalogue Number: 50812G
• Device Lot Number: JUEN1254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 01/05/2021
• 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