MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number 305270

Device Problem Unintended Ejection (1234)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd integra¿ syringe with detachable needle there was an issue with leakage.There was no report of injury or medical intervention.

Manufacturer Narrative

Describe event or problem: it was reported with the use of the bd integra¿ syringe with detachable needle there was an issue with leakage.This occurred on 5 separate occasions but the date/time and or patient information is unknown.There was no report of injury or medical intervention.Investigation summary: five sealed packaged integra syringes were received, confirmed to be from batch #6267660 (p/n 305270).They were visually evaluated.No visual defects were found.All 5 syringes were tested for leakage at the hub by aspirating 3.0ml of water and expelling it forcefully through the attached needles then carefully evaluating the needle to syringe connection points.No leakage was observed in any of the samples.The reported defect was not identified in the 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.

Event Description

It was reported with the use of the bd integra¿ syringe with detachable needle there was an issue with leakage.This occurred on 5 separate occasions but the date/time and or patient information is unknown.There was no report of injury or medical intervention.

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8078523
• MDR Text Key: 127552077
• Report Number: 1213809-2018-00801
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: 30382903052708
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 305270
• Device Lot Number: 6267660
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other