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

Model Number	772514
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	01/24/2021
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 label on some devices stated that there was no sterile gloves in kit, which was not readily apparent to the health care professional during use.This caused the patient to be re-positioned and left to find gloves and then start the process over, hence the procedure was delayed.The patient had restricted supine positing due to spinal sacrectomy and presence of jackson-pratt drains on back.Positioning and re-positioning happened multiple times due to missing gloves in kit.Also reportedly, the kit was missing lubrication for catheter and so an additional kit had to be opened to find lubrication.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "incorrect operation".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: "contents: plastic catheter, 16 fr., preconnected to closed system; collection bag (1000ml approx.Vol.); uro-prep¿ tray with: underpad, drape; povidone-iodine swabsticks (3); specimen container and label; graduated collection container; latex-free gloves (2); lubricant packet.Warning: after use, this 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.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.Remove top tray.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.Top tray may be placed on basin to help prevent spillage.11.Periodic observations of this system should be made to assure that urine is flowing freely." 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 label on some devices stated that there was no sterile gloves in kit, which was not readily apparent to the health care professional during use.This caused the patient to be re-positioned and left to find gloves and then start the process over, hence the procedure was delayed.The patient had restricted supine position due to spinal sacrectomy and presence of jackson-pratt drains on back.Positioning and repositioning happened multiple times due to missing gloves in kit.Also reportedly, the kit was missing lubrication for catheter and so an additional kit had to be opened to find lubrication.

• Brand Name: BARD URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: URETHRAL TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11333260
• Report Number: 1018233-2021-00538
• Device Sequence Number: 935133
• Product Code: KOD
• UDI-Device Identifier: 00801741030444
• UDI-Public: (01)00801741030444
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• 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): 05/14/2021

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: 01/31/2023
• Device Model Number: 772514
• Device Catalogue Number: 772514
• Device Lot Number: NGES0667
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 06/07/2021
• 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