MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD URETHRAL CATHETERIZATION TRAY WITHOUT CATHETER; URETHRAL TRAY

Model Number	802100
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.The device was not returned.
Event or Problem Description
It was reported that there were no syringes in the insertion trays and the gloves underneath everything makes it nearly impossible to stay sterile.Also stated that the manufacturing was not good and it will for sure give a patient an infection.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode could be ¿missing components¿ with a potential root cause of "machine speed out of parameters".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.Remove tray lid.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Open lubricant.Lubricate catheter.6.Open packet of swabs.7.Prep patient with swabs.8.Proceed with catheterization in usual manner.9.If specimen is required, fill sterile container from catheter.10.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory.Warning: after use, the product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations." 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 there were no syringes in the insertion trays and the gloves underneath everything makes it nearly impossible to stay sterile.Also stated that the manufacturing was not good and it will for sure give a patient an infection.

• Brand Name: BARD URETHRAL CATHETERIZATION TRAY WITHOUT CATHETER
• Common Device Name: URETHRAL TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10346622
• Report Number: 1018233-2020-04869
• Device Sequence Number: 19557784
• Product Code: KNX
• UDI-Device Identifier: 00801741051180
• UDI-Public: (01)00801741051180
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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 Expiration Date: 04/01/2023
• Device Model Number: 802100
• Device Catalogue Number: 772100
• Device Lot Number: NGDX4048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1