MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; SAFETY ENGINEERED HYPODERMIC NEEDLE

Catalog Number 305766

Device Problems Bent (1059); Defective Device (2588); Difficult to Open or Close (2921)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation:  a sample is not available for evaluation.Capas (b)(4) were opened to identify and address the potential causes of safety shield disengagement.Additionally, field action notification mss-16-837-fa was initiated and a product advisory letter was sent on 12/29/2016.

Event Description

When using an bd eclipse¿ needle the safety cap was defective and wouldn't close.The needle bent up and stuck her on the index finger.Medical intervention was reported as ¿first aid and serial labs for blood borne infections.".

• Brand Name: BD ECLIPSE¿ NEEDLE
• Type of Device: SAFETY ENGINEERED HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7096018
• MDR Text Key: 94123108
• Report Number: 8041187-2017-00255
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: 30382903057666
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305766
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2017
• 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