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

Model Number	123520A
Medical Device Problem Codes	Collapse (1099); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intermittent catheters were rigid when compared to the old product.Bd representative discussed with nursing staff that this was preferable and it would cause less damage because it made it easier to insert and probably promotes better drainage.Representative was guessing about the old product that was collapsing on itself which was a part of the issue before.Nurse agreed but said that some have noticed a drop of blood.No medical intervention was reported.Per follow-up via phone on 22apr2022, customer felt like it was the end user error and not the product.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to the ¿mechanical failure".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (unknown intermittent catheter) product ifus were found to be adequate based on past reviews.The device was not returned.
Event or Problem Description
It was reported that the intermittent catheters were rigid when compared to the old product.Bd representative discussed with nursing staff that this was preferable and it would cause less damage because it made it easier to insert and probably promotes better drainage.Representative was guessing about the old product that was collapsing on itself which was a part of the issue before.Nurse agreed but said that some have noticed a drop of blood.No medical intervention was reported.Per follow-up via phone on 22apr2022, customer felt like it was the end user error and not the product.

• Brand Name: INTERMITTENT ROCHESTER CATHETERS
• Common Device Name: UNK 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14348065
• Report Number: 1018233-2022-03582
• Device Sequence Number: 5010553
• Product Code: EZC
• UDI-Device Identifier: 00801741095115
• UDI-Public: (01)00801741095115
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022
• 2 Devices were Involved in the Event: 1 2

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: 123520A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 08/08/2022
• 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