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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. 5 FR D/L POWERPICC FULL TRAY

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BARD ACCESS SYSTEMS INC. 5 FR D/L POWERPICC FULL TRAY Back to Search Results
Catalog Number 1275108D
Device Problem Retraction Problem (1536)
Patient Problem Exposure to Body Fluids (1745)
Event Date 06/13/2014
Event Type  Injury  
Event Description
(b)(6) 2014 - helping clean up after a placement, i got stuck with a dirty scalpel.I saw the nurse retract the blade.Placing the sharps in the sharps box i was stuck by the very tip of the blade.The nurse are saying there is no click.(b)(6) 2014 - i did report the injury to the proper people at the hospital and went to the ed for treatment.Blood work was done and i was given prophylactic meds to take for four (4) days.(b)(6) 2014 - clinician received prophylactic treatment for four (4) days while waiting on the patient's test results per facility policy.Test results were negative.No additional treatment was necessary.
 
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of reyd0760 showed no other similar product complaint(s) from this lot number.
 
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Brand Name
5 FR D/L POWERPICC FULL TRAY
Manufacturer (Section D)
BARD ACCESS SYSTEMS INC.
salt lake city UT
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
christy chandonia
605 north 5600 west
salt lake city, UT 84116
8015224963
MDR Report Key3962589
MDR Text Key4611079
Report Number3006260740-2014-00353
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1275108D
Device Lot NumberREYD0760
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 06/18/2014
Initial Date FDA Received07/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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