MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK UNIVERSAL PLUS LARGE 12-14 F CLAMP ON UNIVERSAL PAD INCLUDES SKIN PREP; STAND, INFUSION

Catalog Number	VUPD1214
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of judqf441 showed nine other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that statlock (vupd1214) are not sticking properly, and need to be changed more often than usual.It was stated that so far, in the box users have found 4 or 5 that are defective.On 1/3/2020: quantity was updated to 10 not sticking properly.This report addresses the third of ten devices.

• Brand Name: STATLOCK UNIVERSAL PLUS LARGE 12-14 F CLAMP ON UNIVERSAL PAD INCLUDES SKIN PREP
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9547554
• Report Number: 3006260740-2020-00003
• Device Sequence Number: 19416728
• Product Code: FOX
• 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: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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 Catalogue Number: VUPD1214
• Device Lot Number: JUDQF441
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1