MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CATHETER STABILIZATION DEVICE; STATLOCK DEVICE

Model Number FOL0100

Device Problem Disconnection (1171)

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

Event Date 06/13/2023

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 bard 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 bard.

Event Description

It was reported that customer purchased statlock and after on use the plastic latch came off after one single day use.

Manufacturer Narrative

The reported event is confirmed- cause unknown.Visual inspection noted one (1) used statlock in open packaging.The base and clamp was disconnected from pad.Based on the sample received, the product does not meet specification.The potential root cause could be incorrect conveyor setup.The product was used for patient diagnostic or treatment.The product was influenced by the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review is not required because labeling could not have prevented the reported failure.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.

Event Description

It was reported that customer purchased statlock and after on use the plastic latch came off after one single day use.

• Brand Name: CATHETER STABILIZATION DEVICE
• Type of Device: STATLOCK DEVICE
• 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: 17259528
• MDR Text Key: 318673109
• Report Number: 1018233-2023-04907
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• 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,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FOL0100
• Device Catalogue Number: FOL0100
• Device Lot Number: JUGU8131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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