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

Model Number 305270

Device Problems Leak/Splash (1354); Failure to Deliver (2338); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd integra syringe with detachable needle plunger was difficult to move and the needle retracted prematurely.This was discovered during use.The following information was provided by the initial reporter: material no: (b)(4), batch no: 9001856.It was reported hard to press plunger than all of sudden needle retracts.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/26/2020.H.6.Investigation: one 3ml integra syringe in an opened blister pack from batch 9001856 (p/n 305270) was received and evaluated.It appeared the retraction mechanism activated as expected.The plunger rod was in the bottom out position and the cannula was concealed.No defect was observed.Physical unused samples are required to test for any retraction related issues.No defect was observed in the sample received.Furthermore, the verbatim describes normal product function.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 that bd integra¿ syringe with detachable needle plunger was difficult to move and the needle retracted prematurely.This was discovered during use.The following information was provided by the initial reporter: material no: 305270 batch no: 9001856 it was reported hard to press plunger than all of sudden needle retracts.

• 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: 10368863
• MDR Text Key: 203111440
• Report Number: 1213809-2020-00510
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 305270
• Device Catalogue Number: 305270
• Device Lot Number: 9001856
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other