MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Leak/Splash (1354); Delivered as Unsterile Product (1421); Material Protrusion/Extrusion (2979)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: 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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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 Description

It was reported that 55 unspecified bd safetyglide¿ syringe needles clogged during use, 33 were unable to inject medicine, 50 needles detached from their syringes, 34 needles pulled out of their hubs, 1 syringe leaked, and 10 syringes' safety systems would not close.Additionally, 2 needles caused dirty needle stick injuries prior to safety mechanism activation, and 10 needles caused dirty needle stick injuries when the safety mechanism had already been activated.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "it was reported via survey response that the clinicians experienced needlestick injury after patient use prior to safety mechanism activation (2), needlestick injury after patient use after safety mechanism activation (locked over needle) (10), needle clogged (55), unable to inject medications (33), needle detaches from syringe (50), unable to aspirate medications (9), needle dull/blunt (2), scale marking missing/illegible (15), needle pulled out of hub (34), leakage (1), needle bent (15), safety system did not close (10).Additional information related to what leaked and from where states: "insulin" "i don't recall".Additional information related to nsi prior to use states: "the needle went through the base and i pricked myself".Additional information related to nsi after to use states: "injuries to the fleshy part of the fingers."".

• Brand Name: UNSPECIFIED BD SAFETYGLIDE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11631740
• MDR Text Key: 261307169
• Report Number: 2243072-2021-00986
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention