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

Catalog Number 0035380

Device Problem Difficult to Remove (1528)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2023

Event Type  malfunction  

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 Description

It was reported that how much of the foley catheter should be left in the tube when using it to obtain a urine specimen.And reported that the intermittent catheter sometimes a smaller size could be used due to it just being for specimen collection.The possible leaking around the catheter was not as great of a concern if not being placed as an indwelling.And reported that 5 french catheter kits were very secure in the collection tube and some resistance when pulling out the catheter, while the 8 french female catheter kits had very little resistance when pulling out the catheter.It did not fall out on its own but took very little pull to have it become completely dislodged.

Event Description

It was reported that how much of the foley catheter should be left in the tube when using it to obtain a urine specimen.And reported that the intermittent catheter sometimes a smaller size could be used due to it just being for specimen collection.The possible leaking around the catheter was not as great of a concern if not being placed as an indwelling.And reported that 5 french catheter kits were very secure in the collection tube.And some resistance when pulling out the catheter, while the 8 french female catheter kits had very little resistance when pulling out the catheter.It did not fall out on its own but took very little pull to have it become completely dislodged.Per additional information received via email on 19jan2024, they did not have the lot numbers for the devices at celebration where the product that lead to patient harm was used.But the product that they reviewed and experienced easy movement of the catheter within the collection tube was nghn0341.Multiple different lot number of the intermittent 8 french cath kit have been looked at between two campuses.The same concern was voiced with the ease of movement with the 8 french cath within collection tube for all 8 french that were reviewed.The 5 french has a tighter fit within the collection tube and takes greater effort to pull it out.The patient required surgical intervention.

Manufacturer Narrative

The reported event was inconclusive.The conditions of the photo sample did not allow further evaluation.Visual evaluation of the returned photo sample noted one opened (with original packaging), urine specimen kit.Visual inspection of the photo sample noted the reported event was inconclusive.The conditions of the photo sample did not allow further evaluation.A potential root cause for this type of failure could be ¿inlet port of the cap /catheter (fr.) thickness out of specification¿.However, there was insufficient information to confirm this potential root cause.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: "instructions for use: 1.Open package and remove plastic wallet.2.Open plastic wallet and don gloves.3.Pull catheter out of tube to desired length.Lay tube in sterile field.4.Open lubricant and lubricate catheter.5.Open swab packet.Cleanse vaginal area.6.Proceed with catheterization.7.Pull catheter out of top; tighten cover and depress blue spout.8.Fill out label, place on centrifuge tube.Send to lab in normal manner.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.Reorder/ref: (b)(4).Contents: 8 fr.Catheter in centrifuge tube.Povidone-iodine swabs.Vinyl gloves.Label.3 gm lubricant.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician." 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® FEMALE CATH KIT
• Type of Device: FEMALE 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: 18382951
• MDR Text Key: 331202674
• Report Number: 1018233-2023-09138
• Device Sequence Number: 1
• Product Code: FFH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0035380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Other