MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE, 25 G X 5/8 INCH RETRACTING NEEDLE; HYPODERMIC SYRINGE WITH NEEDLE

Catalog Number	305310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use of the bd integra¿ syringe, 25 g x 5/8 inch retracting needles the medication leaked out of the syringe during administration.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.This is the first complaint for the lot# 6139910 for the same defects or symptoms.There was no documentation of issues for the complaint of batch # 6139910 during this production run.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: no root cause can be determined as no samples were received.Rationale: 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 during use of the bd integra¿ syringe, 25 g x 5/8 inch retracting needles the medication leaked out of the syringe during administration.

• Brand Name: BD INTEGRA¿ SYRINGE, 25 G X 5/8 INCH RETRACTING NEEDLE
• Common Device Name: HYPODERMIC SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8147614
• Report Number: 1911916-2018-00728
• Device Sequence Number: 1569600
• Product Code: MEG
• UDI-Device Identifier: 30382903053101
• UDI-Public: 30382903053101
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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 Expiration Date: 05/31/2021
• Device Catalogue Number: 305310
• Device Lot Number: 6139910
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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