MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER

Model Number	772416
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Abrasion (1689); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/26/2022
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.The device was not returned.
Event or Problem Description
It was reported that the plastic catheters caused injury to the patient.No medical intervention was reported.Per follow up on 01feb2022, nurse stated that the patient experienced bleeding and abrasions to the urinary tract as the catheter was not being able to insert correctly due to being met with resistance.Stated that the patient was monitored and given pain meds as needed but no other medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.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.A potential root cause for this failure could be ¿rough or irregular shape protrusions¿.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Lubricate catheter which is pre-attached to collection bag.7.Bag and catheter may be placed in basin until needed.8.Prep patient with povidone-iodine swabsticks.9.Proceed with catheterization in usual manner.10.Top tray may be placed on basin to help prevent spillage.11.Periodic observations of this system should be made to assure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.Volume on collection container has been calibrated without uro-prep¿ tray in place.Directions for taking specimen: after catheter has been inserted into the bladder and an initial flow of urine is seen in the collection bag: 1.Clamp off catheter using white clamp.2.Insert plastic tube (inside bag) into the back of the sample device.3.Open sample device over the sample container.4.Unclamp catheter.5.Allow desired amount of urine to drain into collection container.6.Clamp off catheter.7.Close sampling device.8.Remove plastic tube from back of sampling device.9.Unclamp catheter and allow remainder of urine to drain into the bag.10.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory." 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 plastic catheters caused injury to the patient.No medical intervention was reported.Per follow up on 01feb2022, nurse stated that the patient experienced bleeding and abrasions to the urinary tract as the catheter was not being able to insert correctly due to being met with resistance.Stated that the patient was monitored and given pain meds as needed but no other medical intervention was reported.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC 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: 13561977
• Report Number: 1018233-2022-00722
• Device Sequence Number: 4360174
• Product Code: KOD
• UDI-Device Identifier: 00801741030420
• UDI-Public: (01)00801741030420
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 772416
• Device Catalogue Number: 772416
• Device Lot Number: NGFX2196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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