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

Catalog Number	305283
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(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 that with use a bd integra¿ syringe safety device failed as"on activation needle only partly retracted into syringe.' there was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
Event or Problem Description
It was reported that with use a bd integra¿ syringe safety device failed as "on activation needle only partly retracted into syringe.' there was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
Investigation summary: five sealed integra packaged needles received at bd for investigation, confirmed to be from batch 6263910 (p/n 305313).Additionally, two sealed integra packaged syringes (no needle) confirmed to be from batch 5327742 (p/n 305283).One used partially activated assembled syringe reported to be from batch 5327742 (p/n 305283).The samples were visually evaluated.Five sealed integra packaged needles ¿ no defects found.Two sealed integra packaged ¿ no defects found.One used partially activated ¿ needle is activated about half the length of the cannula.The cutter was inspected for activation comparison to other integra syringes which activated correctly.The cutter was cut through stopper as expected with no defects/imperfections observed.The two sealed syringes from batch 5327742 were tested for needle retraction using two of the needles received from batch 6263910.No needle retraction failures were observed.Needle retraction failures confirmed in one sample out of the seven 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.The potential root cause for the needle retraction failure is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that with use a bd integra¿ syringe safety device failed as"on activation needle only partly retracted into syringe.' there was no report of exposure, injury or medical intervention needed.

• 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: 7638202
• Report Number: 1213809-2018-00390
• Device Sequence Number: 1433085
• Product Code: MEG
• 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,Followup
• Report Date (Section B): 09/19/2018

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: 06/08/2018
• Supplement Date Received by Manufacturer: 06/08/2018; 06/08/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/10/2018; 09/20/2018
• 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