MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE; MAGIC 3 INTERMITTENT CATHETER

Model Number	52608G
Medical Device Problem Code	Fracture (1260)
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 had often experienced the issue with the cone on the intermittent catheter which was found to be cracked or was cracked prior opening the package.They injected drugs into the bladder and therefore used the cone morning and evening.They also felt the size (ch) varied within the same box.It was noticed on different batches but observed within the same batch as well and seems a bit random.Sometimes the intermittent catheter was smaller than ch08 and then it bends when the user tried to insert it, as if it was too weak.Sometimes it was little thicker as well.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "no tooling specification".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.Correction: h.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 device was not returned.
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 was cracked prior opening the package.They injected drugs into the bladder and therefore used the cone morning and evening.They also felt the size (ch) varied within the same box.It was noticed on different batches but observed within the same batch as well and seems a bit random.Sometimes the intermittent catheter was smaller than ch08 and then it bends when the user tried to insert it, as if it was too weak.Sometimes it was little thicker as well.

• Brand Name: MAGIC3 INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE
• Common Device Name: MAGIC 3 INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11044517
• Report Number: 1018233-2020-21844
• Device Sequence Number: 1193248
• 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): 03/10/2021

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: 06/30/2024
• Device Model Number: 52608G
• Device Catalogue Number: 52608G
• Device Lot Number: JUDU0300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 04/02/2021
• 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