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

Model Number	50818G
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
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.
Event or Problem Description
It was reported that two boxes of intermittent coude catheter had orange stripe instead of the correct red stripe on the carton label.All the other information were correct.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.Visual inspection noted one photo sample was received showing two box labels for magic 3 go catheters.Visual evaluation noted that the box labels had the correct information on the labels themselves, but the orange label was used on the packaging.It was verified that this lot number was intended to have a red label on the packaging.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for the reported failure could be ink solution/color.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.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.
Event or Problem Description
It was reported that two boxes of intermittent coude catheter had orange stripe instead of the correct red stripe on the carton label.All the other information were correct.

• Brand Name: MAGIC3 GO MALE COUDE CATHETER WITH SUREGRIP
• Common Device Name: INTERMITTENT COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10469033
• Report Number: 1018233-2020-05546
• Device Sequence Number: 3054979
• Product Code: EZD
• UDI-Device Identifier: 00801741137044
• UDI-Public: (01)00801741137044
• Combination Product (Y/N): N
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 05/28/2023
• Device Model Number: 50818G
• Device Catalogue Number: 50818G
• Device Lot Number: JUES1493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1