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

Model Number	53612
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
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.The device was not returned.
Event or Problem Description
It was reported three of the catheters were not as "smooth" or "coated" and they were difficult to insert, the lubricant was thicker.
Additional Manufacturer Narrative
The reported event was confirmed.There was no definitive root cause determined for the increase in lubricity complaints.It was determined however, that there were several confounding causes that could contribute to lubricity complaints.The fishbone diagram identifies those contributing factors to lubricity and increased complaints rules out categories from being a root cause of the failure mode.The device history record review was not required as the reported event was confirmed capa case.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 three of the catheters were not as ¿smooth¿ or ¿coated¿and they were difficult to insert.It was also stated that the lubricant was thicker.

• 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: 10954006
• Report Number: 1018233-2020-21427
• Device Sequence Number: 16915082
• Product Code: KOD
• UDI-Device Identifier: 00801741068560
• UDI-Public: (01)00801741068560
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/08/2021

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 Expiration Date: 05/28/2025
• Device Model Number: 53612
• Device Catalogue Number: 53612
• Device Lot Number: JUES2098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/03/2021
• 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