MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 INTERMITTENT ROCHESTER CATHETERS

Model Number	51808
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2021
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 the one box of 30 magic3 go intermittent catheter which almost an entire case came with no liquid in the burst packet.It was noted that the patient had been using this product more than 90 days.
Event or Problem Description
It was reported that the one box of 30 magic3 go intermittent catheters almost an entire case came with no liquid in the burst packet.It was noted that the patient had been using this product more than 90 days.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 one box of 30 magic3 go intermittent catheters almost an entire case came with no liquid in the burst packet.It was noted that the patient had been using this product more than 90 days.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "incorrect process parameters".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the (intermittent rochester catheter) product ifus were found to be adequate based on past reviews.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.H3 other text : the device was not returned.

• Brand Name: INTERMITTENT ROCHESTER CATHETERS
• Common Device Name: INTERMITTENT ROCHESTER CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13127108
• Report Number: 1018233-2021-08639
• Device Sequence Number: 16586084
• Product Code: EZD
• UDI-Device Identifier: 00801741097836
• UDI-Public: (01)00801741097836
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2022

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 Model Number: 51808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2021
• Supplement Date Received by Manufacturer: 02/10/2022; 03/29/2022
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 03/08/2022; 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown