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

Model Number	0035640
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the kit was missing the swab-sticks.
Event or Problem Description
It was reported that the kit was missing the swab-sticks.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿missing components / accessories¿.A potential root cause for this failure could be "incorrect operation".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: ¿released 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.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." h11:section a through f - the information provided by bd represents all of 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.

• Brand Name: DAVOL® PEDIATRIC CATH KIT
• Common Device Name: INFANT CATH KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8817070
• Report Number: 1018233-2019-04159
• Device Sequence Number: 2839077
• Product Code: FFH
• UDI-Device Identifier: 00801741045851
• UDI-Public: (01)00801741045851
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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: 01/30/2021
• Device Model Number: 0035640
• Device Catalogue Number: 0035640
• Device Lot Number: NGCT1290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1