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

Model Number	52608G
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 had often experienced the issue with the cone on the intermittent catheter, which was found to be cracked or already cracked when they open the package.They inject the drugs into the bladder and therefore used the cone in the morning and evening.They also feel that the size (ch) was varied within the same box.It has been on different batches, but also within the same batch, it seems a bit random.Sometimes the intermittent catheters were smaller than ch 08, and then it bends when the user tried to insert it, as it was too weak.Also, sometimes it was a little thicker.
Event or Problem Description
It was reported that the user had often experienced the issue with the cone on the intermittent catheter, which was found to be cracked or already cracked when they open the package.They inject the drugs into the bladder and therefore used the cone in the morning and evening.They also feel that the size (ch) was varied within the same box.It has been on different batches, but also within the same batch, it seems a bit random.Sometimes the intermittent catheters were smaller than ch 08, and then it bends when the user tried to insert it, as it was too weak.Also, sometimes it was a little thicker.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted 14 opened and 1 unopened magic 3 intermittent catheters were received.Visual evaluation noted the catheter funnel had cracks and tears on them.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure mode could be due to" no tooling specification." the product was not used for diagnosis or treatment.The product had failed to meet the specifications, and was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.Correction: d.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.

• 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
• MDR Report Key: 11044486
• Report Number: 1018233-2020-21834
• Device Sequence Number: 13769418
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2021

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: 05/28/2023
• Device Model Number: 52608G
• Device Catalogue Number: 52608G
• Device Lot Number: JUCT0021
• 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: 02/01/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/24/2021
• 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