MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD INTEGRA¿ SYRINGE

Catalog Number	305283
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2018
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 a 3 ml bd integra¿ syringe experienced foreign matter contamination prior to use.
Event or Problem Description
It was reported that a 3 ml bd integra¿ syringe experienced foreign matter contamination prior to use.
Additional Manufacturer Narrative
Investigation: two 3ml ll integra syringes were received and visually inspected.One was loose and one was in a blister pack from batch #8036897 (p/n 305283).The foreign matter described in the loose syringe was observed and identified as part of the needle retraction mechanism ¿ the metal piece found is part of the mechanism that works to retract the integra needle.The sealed sample was also inspected, no defects were found.Root cause not defined since defects were not confirmed in samples received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Additional Manufacturer Narrative
Per additional information received, the device manufacture date has been updated.The following information has been updated: device manufacture date: 2018-02-05.
Event or Problem Description
It was reported that a 3 ml bd integra¿ syringe experienced foreign matter contamination prior to use.

• Brand Name: 3 ML BD INTEGRA¿ SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8241314
• Report Number: 1213809-2018-01000
• Device Sequence Number: 2198773
• Product Code: FMF
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2019

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: 01/31/2023
• Device Catalogue Number: 305283
• Device Lot Number: 8036879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 12/20/2018
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/21/2019; 04/12/2019
• 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