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

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.

• 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 Key: 3962589
• MDR Text Key: 4611079
• Report Number: 3006260740-2014-00353
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• 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 Number: 1275108D
• Device Lot Number: REYD0760
• 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 Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention