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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 SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP STAND, INFUSION

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C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP STAND, INFUSION Back to Search Results
Model Number N/A
Device Problems Misconnection (1399); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Ansm local authorities informed - "it was reported that : the stat-lock device was installed on (b)(6) 2021. This day, by redoing the picc-line dressing, the device was broken in 2, therefore, the catheter did not stay in place as usual, it came out 1 cm. Consequence: risk of infection and risk of mismatching the central catheter, therefore risk of extravasation treatments. ".
 
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Brand NameSTATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
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
kelsey erickson
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12558347
MDR Text Key274240427
Report Number3006260740-2021-04090
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberVPPCSPCE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Yes
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: 09/30/2021 Patient Sequence Number: 1
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