MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK CV ULTRA DUAL POSTED TRICOT PAD, TETHERED LOCKING CAPS. 25 BOX; STAND, INFUSION

Catalog Number	CV0321
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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.A lot history review (lhr) of judsf496 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that "it has occurred for the 2nd time in two different patients that the fixation member releases from the fixation patch.The patch was on the patient's photo, placed on tuesday.The photo shows what the nurse found four days later.Patient has not been in the shower with the patch.This patch is very important for the fixation of (not yet ingrown) tunneled central venous catheters.Releasing has a significant risk of dislocation and infection." this report addresses the first patient.

• Brand Name: STATLOCK CV ULTRA DUAL POSTED TRICOT PAD, TETHERED LOCKING CAPS. 25 BOX
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9655065
• Report Number: 3006260740-2020-00368
• Device Sequence Number: 16564345
• Product Code: FOX
• UDI-Device Identifier: 00801741081576
• UDI-Public: (01)00801741081576
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

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 Expiration Date: 04/28/2022
• Device Catalogue Number: CV0321
• Device Lot Number: JUDSF496
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1