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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST STAND, INFUSION

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C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST STAND, INFUSION Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported the statlock easily detached from the dressing. No other information was provided. It was reported this occurred with two devices. This report addresses the second device.
 
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of jufr1220 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (jufr1220) have been reported from the same facility.
 
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Brand NameSTATLOCK PICC PLUS CRESCENT TRICOT FIX-POST
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 SURGICAL INNOVATIONS -9616067
ave. roberto fierro #6408
parque industrial aeropuerto
cd. juarez, chih s.a. de c.v. 32690
MX 32690
Manufacturer Contact
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12839843
MDR Text Key281030603
Report Number3006260740-2021-04939
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberPIC0222
Device Lot NumberJUFR1220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2021
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: 11/18/2021 Patient Sequence Number: 1
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