MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ SYRINGE WITH NEEDLE

Catalog Number	305927
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
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 with the use of the bd safetyglide¿ syringe with needle there was an issue with foreign matter.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: three photos and 1 physical slip tip syringe with a loose safetyglide shielded needle were received and evaluated.The photos and the syringe appear to be the same sample.The barrel of the syringe was found to have several brown foreign matter pieces embedded in its wall.Furthermore, 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 potential root cause for the embedded foreign matter defect is associated with the molding process.No corrective actions are necessary based on the defective rate identified.
Event or Problem Description
It was reported with the use of the bd safetyglide¿ syringe with needle there was an issue with foreign matter.There was no report of injury or medical intervention.

• Brand Name: BD SAFETYGLIDE¿ SYRINGE WITH NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8018966
• Report Number: 1213809-2018-00742
• Device Sequence Number: 1380603
• Product Code: FMI
• UDI-Device Identifier: 30382903059271
• UDI-Public: 30382903059271
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K951254
• 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): 01/09/2019

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: 10/31/2022
• Device Catalogue Number: 305927
• Device Lot Number: 7310585
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/09/2019
• 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