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

Model Number	53610
Medical Device Problem Codes	Product Quality Problem (1506); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
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 two of the magic 3 go intermittent catheters were bent and unusable, and two had a bubble at the end which made them unusable.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Visual evaluation noted 4 opened intermittent catheters were received.Visual evaluation noted two of the samples received had droopy, twisted tips near the eyelets.See evaluation attachment.This does not meet specifications which shows catheter should be straight with no bends along the length of the catheter.Although an exact root cause could not be determined, a potential root cause is viscometer failure.The product failed to meet specifications.The device history record was reviewed and found nothing 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 two of the magic 3 go intermittent catheters were bent and unusable ((b)(4)and two had a bubble at the end and were unusable.  per additional information received on 22nov2021, patient stated that the solution inside made the magic 3 go intermittent catheters too slippery when opened.Per additional information received on 23feb2022, it was stated that the magic 3 intermittent catheters were difficult to insert after it was lubed.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: MAGIC3 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12820981
• Report Number: 1018233-2021-07277
• Device Sequence Number: 14679010
• Product Code: KOD
• UDI-Device Identifier: 00801741068553
• UDI-Public: (01)00801741068553
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 05/28/2026
• Device Model Number: 53610
• Device Catalogue Number: 53610
• Device Lot Number: JUFS1401
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• 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