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

Model Number	71812
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/18/2020
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 boxes sent had about 8 hydrosil intermittent catheter in it that were not straight and they were bent.Patient used one of the catheter and it had caused pain.Patient did bin the other ones that were bent.Per follow up with the ibc via email on 01feb2021, no photo sample available.The patient could not use and therefore no pain control needed.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to operator error.The device used for the treatment though it was unknown whether the device related to the reported event or met specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that one of the boxes had about 8 hydrosil intermittent catheters that were not straight and they were bent.The patient used one of the catheter and it caused the pain.The patient did with the other ones that were bent.Per follow up with the ibc via email on 01feb2021 there was no photo sample available.The patient could not use and therefore no pain control needed.

• 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: 11398322
• Report Number: 1018233-2021-00886
• Device Sequence Number: 19137422
• Product Code: EZD
• UDI-Device Identifier: 00801741097997
• UDI-Public: (01)00801741097997
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/11/2021

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: 06/28/2023
• Device Model Number: 71812
• Device Catalogue Number: 51812
• Device Lot Number: JUEU0597
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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