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

Model Number	772417
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the uretheral catheter tray had the sterile gloves located under the drape which as a result one was unable to sterially place the drape unless the nurse grabbed own set of gloves (material# 772414-lot# (b)(4).Customer had three trays that have been like this so far the way it was packaged (material# 772417-lot# unk).
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 uretheral catheter tray had the sterile gloves located under the drape which as a result one was unable to sterially place the drape unless the nurse grabbed own set of gloves (material# 772414-lot# ngfz3767).Customer had three trays that have been like this so far the way it was packaged (material# 772417-lot# unk).
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 ¿incorrect operation".The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.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.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER
• Common Device Name: URETERAL TRAY
• 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: 14336926
• Report Number: 1018233-2022-03482
• Device Sequence Number: 5199171
• Product Code: KOD
• UDI-Device Identifier: 00801741030437
• UDI-Public: (01)00801741030437
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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): 07/28/2022

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: 772417
• Device Catalogue Number: 772417
• 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: 04/18/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 05/09/2022
• 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