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

Model Number	53816G
Medical Device Problem Codes	Component Misassembled (4004); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
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 some of the intermittent catheters were not lubricated and it took too long to drain.Per follow up via phone on (b)(6) 2022, it was reported that the customer was still experiencing issues with the urine taking too long to drain.Also stated that there were small holes in the catheter.
Additional Manufacturer Narrative
The reported event is inconclusive as the evaluated representative sample meets specifications and the condition of the original used sample is unknown.Visual evaluation noted 1 magic3go was received in original closed packaging.No burrs, nicks, flashes, and sharps.4 eyelet holes were present on the bottom of the intermittent catheter which meets product specifications.Aside from eyelet holes no additional holes were present on intermittent catheter.Distance from proximal drainage eye was measured.Therefore, product meet specifications.Although an exact root cause could not be determined a potential root cause could be operator error.A review of the dhr did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.H11: section a through f - the information provided by bd represents all 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 some of the intermittent catheters were not lubricated and it took too long to drain.As per follow up via phone on 29nov2022, it was reported that the customer was still experiencing issues with the urine taking too long to drain.Also stated that there were small holes in the catheter as per customer clarification via phone on 18jan2023, customer stated that the holes in the catheter were where they were supposed to be, but they were too small and caused urine backup.

• Brand Name: MAGIC3 GO MALE CATHETER WITH SUREGRIP
• Common Device Name: MAGIC3 GO MALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15997413
• Report Number: 1018233-2022-09614
• Device Sequence Number: 5510733
• Product Code: EZD
• UDI-Device Identifier: 00801741136979
• UDI-Public: (01)00801741136979
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 03/28/2025
• Device Model Number: 53816G
• Device Catalogue Number: 53816G
• Device Lot Number: JUGR9053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male