MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER; MAGIC 3 INTERMITTENT CATHETER

Model Number	53614
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer ordered through liberator and received a total of 12 boxes of intermittent catheter did not have shipping sheet with the order number.Also stated that for 7 of the 12 boxes received, none of the catheters had sleeves on them and they would need replacements.Per follow up via phone on (b)(6) 2023, it was reported that customer understands that they were sent a substitute catheter because the ones they normally used were on backorder without a release date.They also stated that item #53814g lot # jugv1681 had no holes in the tip, and they had samples of that one available.
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 the customer ordered through liberator and received a total of (b)(4) boxes of intermittent catheter did not have shipping sheet with the order number.Also stated that for (b)(4) boxes received, none of the catheters had sleeves on them and they would need replacements.Per follow up via phone on 02april2023, it was reported that customer understands that they were sent a substitute catheter because the ones they normally used were on backorder without a release date.They also stated that item # (b)(4) lot # jugv1681 had no holes in the tip, and they had samples of that one available.
Additional Manufacturer Narrative
Upon further review, bd has determined that this event is not reportable.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 device was not returned.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: MAGIC 3 INTERMITTENT 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: 16725410
• Report Number: 1018233-2023-02497
• Device Sequence Number: 8115825
• Product Code: KOD
• UDI-Device Identifier: 00801741068577
• UDI-Public: (01)00801741068577
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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 Model Number: 53614
• Device Catalogue Number: 53614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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