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

Catalog Number	0035380
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
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 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1018233-2023-09138
• Device Sequence Number: 7806283
• Product Code: FFH
• UDI-Device Identifier: 00801741045820
• UDI-Public: (01)00801741045820
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Other
• Patient Sex: Unknown