MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP; STAND, INFUSION

Catalog Number PIC0220CE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of juev0697 showed two 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 Description

It was reported by facility staff "our dialysis centre informs us that during a dressing change of the dialysis catheter it was noticed that the statlock picc plus was no longer intact.As the statlock is applied as an additional safety measure to keep the dialysis catheter in place, this safety measure was not applicable here.When the dressing was removed, the plastic holder was no longer attached to the adhesive patch that adheres to the patient's skin.After care of the dialysis catheter, a new statlock was applied, but even with this (and the 3rd attempt) it was found that the plastic holder detaches very easily from the adhesive patch to which it is attached." this report addresses the second of three devices.

• Brand Name: STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11819999
• MDR Text Key: 250680418
• Report Number: 3006260740-2021-01829
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIC0220CE
• Device Lot Number: JUEV0697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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