MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® UNIVERSAL CATHETERIZATION TRAY

Catalog Number 792100

Device Problems Incorrect Measurement (1383); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2023

Event Type  malfunction  

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 bard 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 bard.

Event Description

It was reported that in (b)(6) 2021 bard universal catheterization tray was discontinued (lawson # 227022, ref 792100) and was replaced with the item listed above.Urology staff's main concern was when the catheter was inserted, before hooking the drainage bag tubing, they ensure urine flow.The container was too large and square and could not adequately collect urine.They improvised by using a clean graduated cylinder breaking sterility.Another bard catheterization item (lawson # 317827) was used on some units in the region.Clinic staff said this container had similar problems as the ones they currently stock.The request from end user staff for the collection tray to mimic the old discontinued item, similar to the kit of an i/o catheter tray.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "error of inspector".The device was not returned for evaluation.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.H3 other text : the device was not returned.

Event Description

It was reported that in (b)(6) 2021 bard universal catheterization tray was discontinued (lawson # 227022, ref 792100) and was replaced with the item listed above.Urology staff's main concern was when the catheter was inserted, before hooking the drainage bag tubing, they ensure urine flow.The container was too large and square and could not adequately collect urine.They improvised by using a clean graduated cylinder breaking sterility.Another bard catheterization item (lawson # 317827) was used on some units in the region.Clinic staff said this container had similar problems as the ones they currently stock.The request from end user staff for the collection tray to mimic the old discontinued item, similar to the kit of an i/o catheter tray.

• Brand Name: BARD® UNIVERSAL CATHETERIZATION TRAY
• Type of Device: CATHETERIZATION 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18110345
• MDR Text Key: 328633060
• Report Number: 1018233-2023-08034
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741029646
• UDI-Public: (01)00801741029646
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 792100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other