MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; INTRAVASCULAR CATHETER

Catalog Number	306514
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported a bd posiflush¿ heparin lock flush syringe was found cracked and empty of the medication.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Actual sample received.The sample syringe provided has a large crack on the barrel of the syringe and torn flow wrap at the area of the crack.There is also no solution in the syringe.Tip cap is intact.120 retained samples were inspected for similar defects.No defects were found.There have been no other reported complaints for cracked or no solution in the syringe reported within the past year.Dhr: there were no non-conformances, deviations, or issues noted during the manufacture, storage, or distribution of lot 703751n.There was no planned or unplanned equipment maintenance activities performed during the manufacture of lot 703751n that may have contributed to the defects noted in the complaint.The engineering technician evaluated the complaint samples and believes the crack could have occurred at the pick and place of the carton loader machine.The pick and place may have picked the syringes improperly causing damage to the flow wrap and syringe barrel.However, this improper picking could not be replicated during the investigation.Investigation conclusion: confirmed the customer's indicated failure modes of cracked barrel and no solution were confirmed.Root cause: the cracked syringe barrel caused the solution to leak from the syringe.Based on the investigation results to date, root cause of the cracked barrel is believed to be from an isolated carton loading machine issue.

• Brand Name: BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7389741
• Report Number: 2134319-2018-00001
• Device Sequence Number: 11097767
• Product Code: FOZ
• UDI-Device Identifier: 30382903065142
• UDI-Public: 30382903065142
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K011967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/05/2019
• Device Catalogue Number: 306514
• Device Lot Number: 703751N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other