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

Model Number	51816
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
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 one of the packages only had a funnel in it and the intermittent catheter was missing.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.Visual evaluation noted only the catheter handle was received.A potential root cause for this failure could be contamination build up on transfer grippers.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.
Event or Problem Description
It was reported that one of the packages only had a funnel in it and the intermittent catheter was missing.

• Brand Name: MAGIC3 GO INTERMITTENT URINARY CATHETER
• Common Device Name: INTERMITTENT URINARY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11098372
• Report Number: 1018233-2020-22177
• Device Sequence Number: 19091375
• Product Code: EZD
• UDI-Device Identifier: 00801741098086
• UDI-Public: (01)00801741098086
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150345
• 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): 04/21/2021

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: 08/28/2023
• Device Model Number: 51816
• Device Catalogue Number: 51816
• Device Lot Number: JUEV1752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 05/13/2021
• 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