MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL® PEDIATRIC CATH KIT

Catalog Number	0035640
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
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.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.
Event or Problem Description
It was reported that the nurse was using 8 french pediatric catheter kit on a 10 month old baby in order to rule out urinary tract infection.Sterile container fell off catheter on its own during procedure.Also, lube was needed scissors to be opened because the perforations on lube would not let it open.This caused urine to not to be collected and intervention was needed.This caused a urine bag to be placed, but if the urine collected from bag has an abnormal dipstick result, another catheter would be needed to be performed.Another catheter kit with the same lot number was opened and had the same malfunctions as the kit used on the patient.
Event or Problem Description
It was reported that the nurse was using 8 french pediatric catheter kit on a 10 month old baby in order to rule out urinary tract infection.Sterile container fell off catheter on its own during procedure.Also, lube was needed scissors to be opened because the perforations on lube would not let it open.This caused urine to not to be collected and intervention was needed.This caused a urine bag to be placed, but if the urine collected from bag has an abnormal dipstick result, another catheter would be needed to be performed.Another catheter kit with the same lot number was opened and had the same malfunctions as the kit used on the patient.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1sample were confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned sample noted one opened (without original packaging), pediatric catheter in centrifuge tube with lubricant.Visual inspection of the sample noted sterile container fell off catheter easily also, lube perforations on the packing difficult to open.A potential root cause for this failure mode could be ¿incorrect line clearance".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: "single use.Do not resterilize.Do not use if package is damaged.Not made with natural rubber latex.Instructions for use: 1.Open package and remove plastic wallet.2.Open plastic wallet.3.Place infant in supine position, thighs abducted.4.Cleanse the area around the meatus with povidone-iodine swabs.5.Put on sterile gloves.6.Place the tip of the catheter in sterile lubricant and catheterize patient.7.After urine is collected, pull catheter out of cap.8.Tighten cap and depress spout.9.Label centrifuge tube.Important: 1.Use plastic wallet as sterile field.2.Pull catheter out of centrifuge tube to the proper length immediately after donning gloves.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.8 fr.Catheter in centrifuge tube ¿ povidone-iodine swabs ¿ vinyl gloves ¿ 3 gm lubricant ¿ towel ¿ label" 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 actual/suspected device was inspected.

• Brand Name: DAVOL® PEDIATRIC CATH KIT
• Common Device Name: PEDIATRIC CATH KIT
• 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: 17710359
• Report Number: 1018233-2023-06668
• Device Sequence Number: 2149466
• Product Code: FFH
• UDI-Device Identifier: 00801741045851
• UDI-Public: (01)00801741045851
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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: 03/31/2025
• Device Catalogue Number: 0035640
• Device Lot Number: NGGW4673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female