MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK UNIVERSAL PLUS LARGE 12-14 F CLAMP ON UNIVERSAL PAD; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

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.The device has not been returned to the manufacturer for evaluation.

Event Description

It was reported by customer that statlock dressing lifted completely on left side due to purulent drainage.Statlock requires change, same removed.Drain catheter held in situ with gauze and manual pressure as migrating out.Cavilon applied.New statlock placed and large central line transparent tegaderm to reinforce.Stopcock with iv cap added to maintain a closed system tid for ns 10ml flushes.Patient's 3rd ct guided drain insertion within 1 month.The 2 previous migrated out when secured with statlock.Requested securacath to be place and prevent line migration.Patient was transferred to small rural site.There was no patient injury reported.It was stated this occurred with three devices on the same patient.This report addresses the first device.

• Brand Name: STATLOCK UNIVERSAL PLUS LARGE 12-14 F CLAMP ON UNIVERSAL PAD
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19063050
• MDR Text Key: 340456446
• Report Number: 3006260740-2024-01564
• Device Sequence Number: 1
• Product Code: KMK
• UDI-Device Identifier: 00801741083440
• UDI-Public: (01)00801741083440
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VUPD1214
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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