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

Catalog Number 0035640

Device Problem Fitting Problem (2183)

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

Event Date 08/28/2023

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.H3 other text : the device was not returned.

Event Description

It was reported that the customer had an issue with davol pediatric catheter kit.A few staff have stated that the tube was too lose for the opening of the collection tube.So, the tube that was inserted into the patient, the size of the french seemed to be not correct for the size of the collection tube.Also stated that they ordered what they thought were strep kits using the code for the promotion, but got covid tests.Per follow up via phone on 06sep2023, the staff just stated that something was different, and the handling of the tube was difficult compared to how it usually was.Per additional information received on 07sep2023, all reported information was captured from the customer.The issue they had was with the fitting of the tube from what was initially reported.

Event Description

It was reported that the customer had an issue with davol pediatric catheter kit.A few staff have stated that the tube was too lose for the opening of the collection tube.So, the tube that was inserted into the patient, the size of the french seemed to be not correct for the size of the collection tube.Also stated that they ordered what they thought were strep kits using the code for the promotion, but got covid tests.Per follow up via phone on 06sep2023, the staff just stated that something was different, and the handling of the tube was difficult compared to how it usually was.Per notification from ucc on 07sep2023, all reported information was captured from the customer.The issue they had was with the fitting of the tube from what was initially reported.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product had not caused the reported failure.Visual evaluation of the returned sample noted four opened (without original packaging), pediatric catheter kits.Visual inspection of the sample noted all four of the peds cath kit fit tightly in the collection tube and was measured (8fr).As the reported event is unconfirmed a dhr review is not required.However, a dhr was completed before unconfirming the event as the reported event is unconfirmed a labeling review is not required.Correction: 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.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inlet port of the cap / catheter (fr.) thickness out of specification".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: ¿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.¿ 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 customer had an issue with davol pediatric catheter kit.A few staff have stated that the tube was too lose for the opening of the collection tube.So, the tube that was inserted into the patient, the size of the french seemed to be not correct for the size of the collection tube.Also stated that they ordered what they thought were strep kits using the code for the promotion, but got covid tests.Per follow up via phone on (b)(6) 2023, the staff just stated that something was different, and the handling of the tube was difficult compared to how it usually was.Per additional information received on 07sep2023, all reported information was captured from the customer.The issue they had was with the fitting of the tube from what was initially reported.

• Brand Name: DAVOL® PEDIATRIC CATH KIT
• Type of Device: PEDIATRIC CATHETER
• 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: 17745327
• MDR Text Key: 323399074
• Report Number: 1018233-2023-06775
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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: NGHQ1280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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