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	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 leakage.It was stated ¿the syringes come apart when removing from the patient or giving medication.In addition, when drawing up medication to give an iv the syringe have to be switch because there's no luerlock for needless system.¿ there was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: no samples including photos were returned for evaluation.Complaint is for lack of luer-lok on the syringe.This product includes a slip tip syringe by design - it is not a defect.Dhr review is not required due to complaint being for product design.Investigation conclusion: this product includes a slip tip syringe by design - it is not a defect.
Event or Problem Description
It was reported with the use of the bd safetyglide¿ syringe with needle there was an issue with leakage.It was stated ¿the syringes come apart when removing from the patient or giving medication.In addition, when drawing up medication to give an iv the syringe have to be switch because there's no luerlock for needless system.¿ there was no report of injury or further medical intervention.
Event or Problem Description
It was reported with the use of the bd safetyglide¿ syringe with needle there was an issue with leakage.It was stated ¿the syringes come apart when removing from the patient or giving medication.In addition, when drawing up medication to give an iv the syringe have to be switch because there's no luerlock for needless system.¿ there was no report of injury or further medical intervention.
Additional Manufacturer Narrative
A device history record review showed no rejected inspections during the production of the provided lot number that could have contributed to the reported defect.

• 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: 7519120
• Report Number: 1213809-2018-00320
• Device Sequence Number: 19165863
• Product Code: FMI
• UDI-Device Identifier: 30382903059271
• UDI-Public: 30382903059271
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2018

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 305927
• Device Lot Number: 7310585
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 05/04/2018; 05/04/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 07/30/2018; 08/21/2018
• 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