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

Catalog Number 0035640

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿components damage ¿ received from supplier".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: "infant and pediatric cath kits: information for use: caution: read all instructions prior to use.Indications: bladder catheterization is performed when a sterile urine sample is needed and a clean catch specimen cannot be obtained.Warnings: the catheter should never be forced if resistance is felt.Trauma to the bladder (false passage) can be prevented by adequately lubricating the catheter and stretching the penis to straighten the urethra.Sterile: sterile unless package is opened or damaged.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Instructions: 1.Open plastic wallet, which may be used as a sterile field.The following four steps apply only to male catheterization: 2.Place the infant supine, with the thighs abducted (frog-leg position).3.Cleanse the penis with povidone-iodine swabs, starting with the meatus and moving in a proximal direction.4.Put on sterile gloves.Remove protective sheath from catheter and pull catheter out of centrifuge tube to desired length.Lay tube assembly on the sterile field.5.Place the tip of the catheter in sterile lubricant.Hold the penis perpendicular to the body to straighten the penile urethra and help prevent false passage.Advance the catheter carefully until urine appears.A slight resistance may be felt as the catheter passes the external sphincter.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.6.After urine is collected, pull catheter out of the cap of the centrifuge tube.Tighten cap and depress spout.7.Fill out label and place on centrifuge tube.Send to lab in normal manner.Instructions: 1.Open plastic wallet, which may be used as a sterile field.The following four steps apply only to female catheterization: 2.Place the infant supine, with the thighs abducted (frog-leg position).3.Separate the labia and cleanse the area around the meatus with the povidone-iodine swabs.Use anterior-to-posterior strokes to prevent fecal contamination.4.Put on sterile gloves.Remove protective sheath from catheter and pull catheter out of centrifuge tube to desired length.Lay tube assembly on the sterile field.5.Place the tip of the catheter in sterile lubricant.Spread the labia with two fingers and carefully advance the catheter until urine appears.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.6.After urine is collected, pull catheter out of the cap of the centrifuge tube.Tighten cap and depress spout.7.Fill out label and place on centrifuge tube.Send to lab in normal manner." 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 device was not returned.

Event Description

It was reported that the physician ordered a catheter to be catheterized on the 10 months old patient.They prepared the area, inserted the catheter, the catheter broke away from the plastic cup that catches the urine.No harm to the patient.Several other catheter kits with the same lot number were opened and were noted to have the same concern.

• Brand Name: DAVOL® PEDIATRIC CATH KIT
• Type of Device: DAVOL® 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: 17930327
• MDR Text Key: 325604389
• Report Number: 1018233-2023-07418
• Device Sequence Number: 1
• Product Code: FFH
• UDI-Device Identifier: 00801741045851
• UDI-Public: (01)00801741045851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0035640
• Device Lot Number: NGGV0947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other