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

Model Number	53312
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
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.The device was not received.
Event or Problem Description
It was reported that each catheter has a different size.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.Visual evaluation noted 526 unopened samples in original box packaging.The samples were tested according to the general inspection level ii/single sampling plan.All catheters' outer dimensions were measured.Measurements were found to be out of specification (0.157" +/- 0.013").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: "for urological use only.Urinary catheters are intended for use for bladder management including urine drainage, collection and measurement.The devices are passed to the urinary bladder via the urethra.Warnings: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.How to prepare and use your urinary catheter 1.Wash your hands thoroughly with soap and water.2.Peel open the pack at the funnel end to expose approximately 2¿- 4¿ of the catheter.Don¿t remove the catheter yet.3.Wash the area around the meatus before catheterizing.4.Wash your hands again.5.Using the catheter: with sure-grip¿ sleeve: a.Hold the sure-grip¿ sleeve with your dominant hand and squeeze it to hold the catheter shaft as you remove the catheter from the pack.B.Next, hold the catheter funnel above the sure-grip¿ sleeve with your other hand and slide the sure-grip¿ sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.C.Using the sure-grip¿ sleeve to hold the catheter firmly, lubricate catheter tip with lubricating gel.D.While gripping the catheter with the sure-grip¿ sleeve, gently pass the tip of the catheter into your urethra until the sure-grip¿ sleeve nears the meatus.If there is no urine flow, loosen the tension on the sure-grip¿ sleeve to allow it to slide back towards the funnel end.Re-grip sure-grip¿ sleeve and continue to insert the catheter into the urethra.Repeat until urine starts to flow.Without sure-grip¿ sleeve: a.Remove the catheter from the pack.B.Lubricate the catheter tip with lubricating gel.C.Gently pass the tip of the catheter into your urethra and advance the catheter until urine starts to flow.6.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.7.Finish by disposing of the catheter and its packaging.8.Wash your hands with soap and water.".
Event or Problem Description
It was reported that each catheter has a different size.Additional information was received via email on 3 april 2019 from the international business center representative, that the allegation was against the thickness of the catheters.The thickness of the catheters were non-uniform.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation noted 526 unopened samples in original box packaging.The samples were tested according to general inspection level ii/single sampling plan.All catheters tested measured to be 12fr.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: "for urological use only.Urinary catheters are intended for use for bladder management including urine drainage, collection and measurement.The devices are passed to the urinary bladder via the urethra.Warnings: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.How to prepare and use your urinary catheter 1.Wash your hands thoroughly with soap and water.2.Peel open the pack at the funnel end to expose approximately 2¿- 4¿ of the catheter.Don¿t remove the catheter yet.3.Wash the area around the meatus before catheterizing.4.Wash your hands again.5.Using the catheter: with sure-grip¿ sleeve: a.Hold the sure-grip¿ sleeve with your dominant hand and squeeze it to hold the catheter shaft as you remove the catheter from the pack.B.Next, hold the catheter funnel above the sure-grip¿ sleeve with your other hand and slide the sure-grip¿ sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.C.Using the sure-grip¿ sleeve to hold the catheter firmly, lubricate catheter tip with lubricating gel.D.While gripping the catheter with the sure-grip¿ sleeve, gently pass the tip of the catheter into your urethra until the sure-grip¿ sleeve nears the meatus.If there is no urine flow, loosen the tension on the sure-grip¿ sleeve to allow it to slide back towards the funnel end.Re-grip sure-grip¿ sleeve and continue to insert the catheter into the urethra.Repeat until urine starts to flow.Without sure-grip¿ sleeve: a.Remove the catheter from the pack.B.Lubricate the catheter tip with lubricating gel.C.Gently pass the tip of the catheter into your urethra and advance the catheter until urine starts to flow.6.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.7.Finish by disposing of the catheter and its packaging.8.Wash your hands with soap and water." corrections: d10, h3.
Event or Problem Description
It was reported that each catheter has a different size.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8097015
• Report Number: 1018233-2018-05613
• Device Sequence Number: 11334142
• Product Code: KOD
• UDI-Device Identifier: 00801741068416
• UDI-Public: (01)00801741068416
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2019

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 Expiration Date: 09/28/2022
• Device Model Number: 53312
• Device Catalogue Number: 53312
• Device Lot Number: JUBW0454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 02/08/2019; 04/24/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 02/27/2019; 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1