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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK POSTED NEONATE PAD INCLUDES SALINE WIPE STAND, INFUSION

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C.R. BARD, INC. (BASD) -3006260740 STATLOCK POSTED NEONATE PAD INCLUDES SALINE WIPE 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 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of juep1098 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that neonatal statlock plastic posts are not adhered to the adhesive pad. The posts started to let go after applying to the patient which almost resulted in a line migration in a neonate, a significant safety risk.
 
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Brand NameSTATLOCK POSTED NEONATE PAD INCLUDES SALINE WIPE
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 Key12517151
MDR Text Key272884533
Report Number3006260740-2021-03927
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 company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberNN0200
Device Lot NumberJUEP1098
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2020
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: 09/22/2021 Patient Sequence Number: 1
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