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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 10/20/2021
Event Type  malfunction  
Event Description
It was reported by healthcare professional "i was doing my picc dressing over the weekend and noticed a product irregularity with the stat locks. The old stat lock plastic piece pulled off of the adhesive section when i pulled the dressing off of the patient. ".
 
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of juey2761 showed no other similar product complaint(s) from this lot number.
 
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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
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12797476
MDR Text Key280816471
Report Number3006260740-2021-04803
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
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 NumberJUEY2761
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2020
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: 11/11/2021 Patient Sequence Number: 1
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