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

Model Number	771215
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 there was no urine got back into the bag, when the catheter was fully inserted.Mss advised the user to make sure that the clamp was released.
Event or Problem Description
It was reported that there was no urine got back into the bag, when the catheter was fully inserted.Mss advised the user to make sure that the clamp was released.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to an "operator error" during the punching process.The device was used for treatment, though it was unknown if the device was related to the reported event or met specifications since a sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.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.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.

• Brand Name: BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10271092
• Report Number: 1018233-2020-04499
• Device Sequence Number: 3557679
• Product Code: EYB
• UDI-Device Identifier: 00801741030499
• UDI-Public: (01)00801741030499
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 771215
• Device Catalogue Number: 771215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1