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
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3006260740-2024-01564
• Device Sequence Number: 6603094
• Product Code: KMK
• UDI-Device Identifier: 00801741083440
• UDI-Public: (01)00801741083440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown