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

Catalog Number	305283
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported lot # 73349676 was not found for the reported catalog # 305283.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd integra¿ syringe leaked at the connection site during use, requiring a second shot of vaccine medication.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "there has been noted leakage at the connection of the needle and syringe, as of today (october 25th) more than a dozen have been leaking at the connection site." "because of the incidents the vaccine was under dosed requiring another shot.".
Event or Problem Description
It was reported that the bd integra¿ syringe leaked at the connection site during use, requiring a second shot of vaccine medication.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "there has been noted leakage at the connection of the needle and syringe, as of today (october 25th) more than a dozen have been leaking at the connection site." "because of the incidents the vaccine was under dosed requiring another shot.".
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number provided is not a bd batch # recognized in the system.

• Brand Name: BD INTEGRA SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9354822
• Report Number: 1213809-2019-01149
• Device Sequence Number: 459277
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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 Catalogue Number: 305283
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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