MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ALL PURPOSE URETHRAL CATHETER

Model Number	0094140
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
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 red rubber intermittent catheter was flimsy and the patient felt that it was made differently.Per follow up via phone on (b)(6) 2021 the customer noticed a change in the catheters they used for years.The catheters were flimsy which makes them difficult to use.They feel like the diameter was smaller than the indicated 14 fr.
Event or Problem Description
It was reported that the red rubber intermittent catheter was flimsy and the patient felt that it was made differently.Per follow up via phone on 17aug2021 the customer noticed a change in the catheters they used for years.The catheters were flimsy which makes them difficult to use.They feel like the diameter was smaller than the indicated 14 fr.
Additional Manufacturer Narrative
The reported event was unconfirmed because the device meets specifications.The product was used for treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A red all purpose catheter was returned unopened in original packaging.No visual defects were noted.A dhr review was not required as the investigation was unconfirmed.As the reported event is unconfirmed a risk review and labeling review is not required.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: BARD® ALL PURPOSE URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• 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: 12448826
• Report Number: 1018233-2021-05543
• Device Sequence Number: 16971281
• Product Code: KOD
• UDI-Device Identifier: 00801741034022
• UDI-Public: (01)00801741034022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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 Expiration Date: 03/31/2025
• Device Model Number: 0094140
• Device Catalogue Number: 0094140
• Device Lot Number: NGEX3236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2020
• 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