MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD SAFETYGLIDE INSULIN SYRINGE W/ ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number 305903

Device Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Additional medical device type: fmi.Additional common device name: hypodermic single lumen needle.Medical device expiration date: unknown.Pma/510(k)#: k980580 (syringe), k951254 (needle).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 1 ml bd safetyglide¿ insulin syringe w/ attached needle had a safety mechanism failure.This was discovered during use.The following information was provided by the initial reporter: material no.: 305903, batch no.: unknown (reported: all lots).It was reported that the safety mechanism is causing near misses and the needle is coming apart from the syringe.Concern description: since new product has appeared we have had 4 psls re.The new vitamin k syringes (bd safetyglide) 1 ml 25 g 5/8 luer slip syringe.The nurses would like to have them changed back to luer lock syringes.Issues are the safety mechanism causing near misses and the needle coming apart from the syringe.

Event Description

It was reported that 1 ml bd safetyglide¿ insulin syringe w/ attached needle had a safety mechanism failure.This was discovered during use.The following information was provided by the initial reporter: material no.: 305903 batch no.: unknown (reported: all lots).It was reported that the safety mechanism is causing near misses and the needle is coming apart from the syringe.Concern description: since new product has appeared we have had 4 psls re.The new vitamin k syringes (bd safetyglide) 1 ml 25 g 5/8 luer slip syringe.The nurses would like to have them changed back to luer lock syringes.Issues are the safety mechanism causing near misses and the needle coming apart from the syringe.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.The complaint is unconfirmed and the root cause could not be determined.H3 other text: see h.10.

• Brand Name: 1 ML BD SAFETYGLIDE INSULIN SYRINGE W/ ATTACHED NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8900901
• MDR Text Key: 157428433
• Report Number: 1213809-2019-00836
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other