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

Model Number	52608G
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
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 the user experienced an issue with the cone on the intermittent catheter which was found to be cracked or already cracked when opening the package.The catheters are used twice a day to inject drugs into the bladder.It was also reported that the size (ch) was varied within the same box.It was reported on different batches and on catheters in the same batch.Sometimes the intermittent catheters were smaller than ch 08, and then it bends when the user tries to insert it.It was also reported that the catheters were a little thicker.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual inspection noted 1 opened magic 3 intermittent catheter was received.Visual evaluation noted no obvious defects.Further testing was required.The outer diameter of the catheter measured to be 0.0975" which was found to be within specification (0.105" +/- 0.013").The product was not used for diagnosis or treatment.It was determined that the product had no relationship to the event due to the investigation being unconfirmed through sample evaluation.The product met 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 bd 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 bd.H3 other text: the actual/suspected device was inspected.
Event or Problem Description
It was reported that the user experienced an issue with the cone on the intermittent catheter which was found to be cracked or already cracked when opening the package.The catheters are used twice a day to inject drugs into the bladder.It was also reported that the size (ch) was varied within the same box.It was reported on different batches and on catheters in the same batch.Sometimes the intermittent catheters were smaller than ch 08, and then it bends when the user tries to insert it.It was also reported that the catheters were a little thicker.

• Brand Name: MAGIC3 INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE
• Common Device Name: MAGIC3 INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11044518
• Report Number: 1018233-2020-21845
• Device Sequence Number: 1193249
• Product Code: KOD
• UDI-Device Identifier: 00801741069680
• UDI-Public: (01)00801741069680
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 52608G
• Device Catalogue Number: 52608G
• Device Lot Number: JUDU0300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 03/11/2021
• 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