MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 COUDE INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE; INTERMITCOUDEMAG3HYDROMAL50618

Model Number	50618
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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 3 boxes of 30 replaced intermittent catheters were also seemed to be dry, as they were lacking the hydrophilic coating.
Event or Problem Description
It was reported that (b)(4) boxes of (b)(4) replaced intermittent catheters were seemed to be dry, as they were lacking the hydrophilic coating.Per follow up made (b)(6)2021, the customer was requested size 16f catheter, thinking the problem only existed with the size 18f, but the problem also existed in the 16f size catheter.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "operator error".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "intended use: the catheter is intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/ precautions and adverse reactions.¿ wash your hands thoroughly with soap and water.¿ release the sterile water from the foil packet.¿ tip the catheter pouch end-to-end three to six times so the water moves back and forth to thoroughly wet the catheter surface.¿ peel open the pack at the funnel end just enough to expose the insertion sleeve.Don¿t remove the catheter yet.Use the adhesive tab at the funnel end of the pack to stick the pack to a nearby vertical surface while preparing to catheterize.¿ wash the area around the meatus before catheterizing.¿ wash your hands again.Hold the insertion sleeve with your dominant hand and squeeze it to grip the catheter shaft as you remove the catheter from the pack.¿ next, hold the catheter funnel above the insertion sleeve with your other hand and slide the insertion sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.¿ using the insertion sleeve to hold the catheter firmly, gently pass the tip of the catheter into your urethra until the insertion sleeve nears the meatus.Repeat until urine starts to flow.¿ try to keep the catheter steady until urine stops flowing.When urine stops flowing, slowly withdraw the catheter, stopping if flow starts again, until the last few drops have drained.¿ finish by disposing of the catheter and its packaging.Wash your hands with soap and water.Warning: ¿ this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.¿ urethral catheter for urological use only.Discard after use.Made of silicone elastomer." 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.

• Brand Name: MAGIC3 COUDE INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE
• Common Device Name: INTERMITCOUDEMAG3HYDROMAL50618
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11345504
• Report Number: 1018233-2021-00649
• Device Sequence Number: 728883
• Product Code: KOD
• UDI-Device Identifier: 00801741068102
• UDI-Public: (01)00801741068102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• 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): 05/18/2021

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: 05/28/2025
• Device Model Number: 50618
• Device Catalogue Number: 50618
• Device Lot Number: JUES2068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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