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

Model Number	771114
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
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 yellow sticker on the urethral catheterization kit states that there were no sterile gloves in the package.There was no mention of the lubricant, and certainly the issue of the catheter detached from the bag.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿incorrect operation¿.It was 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.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.Open catheter lubricating jelly.6.Lubricate catheter which is pre-attached to collection bag.(bag and catheter may be placed in tray until needed.) 7.Prep patient with povidone-iodine swabsticks.8.Proceed with catheterization in usual manner.9.Periodic observations of this system should be made to assure that urine is flowing freely.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 yellow sticker on the urethral catheterization kit states that there were no sterile gloves in the package.There was no mention of the lubricant, and certainly the issue of the catheter detached from the bag so easily was concerning.

• Brand Name: BARD URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: BARD URETHRAL CATHETERIZATION TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10671433
• Report Number: 1018233-2020-20100
• Device Sequence Number: 16830303
• Product Code: KOD
• UDI-Device Identifier: 00801741030482
• UDI-Public: (01)00801741030482
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: 06/30/2022
• Device Model Number: 771114
• Device Catalogue Number: 771114-BARD
• Device Lot Number: NGER3275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other