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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV ULTRA STAND, INFUSION

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C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV ULTRA STAND, INFUSION Back to Search Results
Catalog Number IVK0100
Device Problems Inadequate Instructions for Healthcare Professional (1319); Loose or Intermittent Connection (1371); Misconnection (1399)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of judz2100 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported via ms&s "nurse caller with bd insyte autoguard bc pro (reference# (b)(4). Lot# 9248850) using in conjunction with bard/bd statlock iv ultrastabilization device (reference#: (b)(4), lot#: judz2100) states nurses in her hospital are losing iv accesses and are frustrated that the two products do not seem to be working together and this is what her hospital has supplied them. Caller also emailed pictures of products with email: "hi, here are photos of the catheter and the statlock device that we have been provided at our hospital. We did not get an in-service on using the statlock device. Many nurses are trying to put the device on as in the first picture which does not secure the catheter at all. The second picture shows what appears to be the proper way to use it although it¿s still not all that secure. The catheter still moves under the device and does not appear to actually lock it in place. " ms&s responded "asked caller to email me pictures of products and she emailed six photos (attached here). Emailed response to caller as follows per request:"hi, thank you for reaching out today. I received the six pictures you sent and have attached them all here for reference. As i mentioned, i will be forwarding this case to our filed assurance/quality department for review related to your issues with the bard/bd statlock iv ultra stabilization device with the bd insyte autoguard bc pro. With regard to the bard/bd statlock used with the bd insyte autoguard iv catheters, we understand it typically to be that the bard/bd statlock iv ultra stabilization device https://www. Bardaccess. Com/products/stabilization/piv-ultra is used for non-winged sets and the bard/bd statlock iv select https://www. Bardaccess. Com/products/stabilization/piv-select is used for winged sets. The bard/bd statlock iv select can also be used for nonwinged sets. I have attached documents for your review. In the bd insyte autoguard¿ bc pro (points to practice in-service manual) from the webpage: https://www. Bd. Com/en-us/offerings/capabilities/vascular-access/vascular-iv-catheters/peripheral-iv-catheters/insyte-autoguard-bc-proshielded- iv-catheter-with-blood-control-technology where it states ¿stabilize the catheter and apply a sterile dressing according to your policy. ¿ in the attached i. V. Select stabilization device wallchart at: https://www. Bardaccess. Com/products/stabilization/piv-select where it provides a securement visual to include the statement ¿3. Apply adhesive strip or sterile transparent dressing per hospital protocol. ¿ there are three bard/bd. Statlock iv select stabilization device application, removal, and in-service videos at: https://www. Bardaccess. Com/products/stabilization/piv.
 
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Brand NameSTATLOCK IV ULTRA
Type of DeviceSTAND, INFUSION
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
DAVOL INC. -1223089
160 new boston st.
woburn MA 01801
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key10876214
MDR Text Key219198261
Report Number3006260740-2020-20594
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIVK0100
Device Lot NumberJUDZ2100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/20/2020 Patient Sequence Number: 1
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