MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number 305903

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Pma/510(k)#: k980580(syringe) k951254(needle).Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.

Event Description

Material no.: 305903, batch no.: unknown.It was reported that during use of the bd safetyglide¿ insulin syringe with attached needle the safety mechanism is difficult to engage.This occurred on 4 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: safety mechanism is difficult to engage requiring people to report near misses (when engaging the safety, the needle can easily come apart from the syringe).

• Brand Name: BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8934935
• MDR Text Key: 155709481
• Report Number: 1213809-2019-00864
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2019
• 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): Other