MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® URETHRAL CATHETER WHISTLE TIP

Catalog Number	055016
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
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.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.
Event or Problem Description
It was reported that they were long timer users of the whistle tip and upon starting to use the catheter it did not fit as a 16fr should.As per the follow up received on 06jul2023, the sales representative responded that the one that was used and clearly noticed in use was not a 16fr.It was thrown away.And the customer was given four unopened catheters that they described as 16fr, but when compared with a different lot of 16fr, they were clearly smaller.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.Four samples were confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted four unopened (with original packaging), urethral catheters.Visual inspection of the sample noted urethral catheters was measured (15fr) and the outside packing indicates (16fr).This does not meet specification, dimensions (per individual specification) tolerance: +/-1/16¿ unless otherwise specified.A potential root cause for this failure mode could be ¿inadequate feeding on pre-printed paper machine".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: ¿bard® urethral catheter warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions.Single use caution, consult accompanying documents.Do not use if package is damaged.Do not resterilize.Authorized representative in the european community consult instructions for use.Sterilized by irradiation or sterilized by ethylene oxide.Refer to direct unit label for sterilization method utilized caution: federal (usa) law restricts this device to sale by or on the order of a physician.Bard and bardex are trademarks and/or registered trademarks of c.R.Bard, inc.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.¿ 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 actual/suspected device was inspected.
Event or Problem Description
It was reported that they were long timer users of the whistle tip and upon starting to use the catheter it did not fit as a 16fr should.As per the follow up received on 06jul2023, the sales representative responded that the one that was used and clearly noticed in use was not a 16fr.It was thrown away.And the customer was given four unopened catheters that they described as 16fr, but when compared with a different lot of 16fr, they were clearly smaller.

• Brand Name: BARDEX® URETHRAL CATHETER WHISTLE TIP
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17423482
• Report Number: 1018233-2023-05558
• Device Sequence Number: 17622687
• Product Code: KOD
• UDI-Device Identifier: 00801741033254
• UDI-Public: (01)00801741033254
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 055016
• Device Lot Number: NGFX2368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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