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

Catalog Number	305283
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 during use of the bd integra¿ syringe ¿it was hard to push and when 0.2ml of medication remained in the syringe it made a clicking noise while retracting the needle.When removed from patients arm the needle had not retracted.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Dhr review could not be performed due to unknown batch #.Investigation conclusion: root cause and capa not required as no defects were confirmed.

• Brand Name: 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: 7248150
• Report Number: 1213809-2018-00050
• Device Sequence Number: 19099210
• Product Code: FMF
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011103
• 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): 03/24/2018

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 Catalogue Number: 305283
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/28/2018
• 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