MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE

Model Number	53612G
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer received some of the intermittent catheter that were eaten at the top in the last 2 orders.Stated that the catheter was ¿split- chewed¿ in the end (lot# jugw0773, lot# jugt1003).
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the customer received some of the intermittent catheter that were eaten at the top in the last 2 orders.Stated that the catheter was ¿split- chewed¿ in the end (lot# jugw0773, lot# jugt1003).
Additional Manufacturer Narrative
The reported event is confirmed and cause was unknown.Visual inspection noted two (2) photo samples.First and second photo samples showcases isc with a distorted funnel.Also, received two (2) magic 3 iscs in open packaging.The funnel end of both iscs is distorted.Therefore, product does not meet specifications.The potential root cause could be no tooling specification.The product was not used for patient diagnosis or treatment.The product was influenced by the reported failure.A labeling review is not required because labeling could not have prevented the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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 inspected.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
• Common Device Name: 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: 17341905
• Report Number: 1018233-2023-05232
• Device Sequence Number: 17868306
• Product Code: KOD
• UDI-Device Identifier: 00801741069765
• UDI-Public: (01)00801741069765
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 08/18/2023

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: Health Professional
• Device Model Number: 53612G
• Device Catalogue Number: 53612G
• Device Lot Number: JUGW0773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 08/19/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2022
• 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: Unknown