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

Catalog Number 305761

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the reported defect cannot be confirmed as actual sample was not returned for evaluation.Therefore, root cause could not be determined.The complaint will be re-opened and re-investigated if the sample is returned.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of safety shield broke off with lot #8241495 regarding item #305761.Root cause description: he reported defect cannot be confirmed as actual sample was not returned for evaluation.Therefore, root cause could not be determined.The complaint will be re-opened and re-investigated if the sample is returned.Rationale: unable to confirm the customer experience as actual sample was not returned.

Event Description

It was reported that the safety mechanism detached during use with a bd eclipse¿ needle.The following information was provided by the initial reporter: it was reported the needle and safety device detached from the needle when the ma attempted to close the safety device.No injury to pt or employee.Needle attached to flu vaccine discarded into sharp bin.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN 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 ; 8015652341
• MDR Report Key: 9535288
• MDR Text Key: 179135475
• Report Number: 8041187-2019-01051
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903057611
• UDI-Public: 30382903057611
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 305761
• Device Lot Number: 8241495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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