MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE; FLUSH

Catalog Number	306507
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
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 that the 3 ml bd¿ pre-filled normal saline syringe was missing the end of the plunger from the syringe.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one sample unit was provided for evaluation by our quality engineer.Based on the location of the plunger damage, it appears that the damage originated from a jam or a miss-pick within the flow wrapper or carton loader equipment.As the sample was received outside of the flow wrap packaging, it cannot be confirmed whether the damage occurred during the flow wrap packaging process or at a later time.A device history record review did not reveal any issues during the production of lot number 802011c that could have contributed to this issue.A review of the risk management documents was performed.As procedures are currently in place for the observed failure, no updates are needed at this time to the controls, ratings, or hazards.The root cause of this issue has been identified equipment failure.A picture of the defective product will be posted near the packaging rooms for employee awareness.Corrective actions are being implemented under capa (b)(4).
Event or Problem Description
It was reported that the 3 ml bd¿ pre-filled normal saline syringe was missing the end of the plunger from the syringe.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Correction: additional information was received indicating that the plunger rod was broken and missing its thumb press prior to use.This would render the device inoperable before use and therefore does not meet our mdr reporting criteria for a reportable malfunction.
Event or Problem Description
It was reported that the 3 ml bd¿ pre-filled normal saline syringe was missing the end of the plunger from the syringe.There was no report of exposure, serious injury or medical intervention.Correction: additional information was received indicating that the plunger rod was broken and missing its thumb press prior to use.This would render the device inoperable before use and therefore does not meet our mdr reporting criteria for a reportable malfunction.

• Brand Name: 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE
• Common Device Name: FLUSH
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7694644
• Report Number: 2134319-2018-00088
• Device Sequence Number: 904324
• Product Code: FOZ
• UDI-Device Identifier: 30382903065074
• UDI-Public: 30382903065074
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K011982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2018

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: 01/19/2021
• Device Catalogue Number: 306507
• Device Lot Number: 802011C
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 06/22/2018; 06/22/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 07/19/2018; 09/17/2018
• 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