MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE¿ NEEDLE WITH SLIP-TIP HUB CONFIGURATION; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305895

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use of the bd eclipse¿ needle with slip-tip hub configuration there was leakage at the joint between the syringe and needle.The following information was provided by the initial reporter: when supervising student nurse administered fluad influenza vaccine the vaccine leaked from the joint between the syringe and needle and the majority of the patient did not receive the majority of the vaccine.I checked the needle was correctly secured to the syringe post the incident and it was firmly attached.The needle used was a bd eclipse.

Event Description

It was reported that during use of the bd eclipse¿ needle with slip-tip hub configuration there was leakage at the joint between the syringe and needle.The following information was provided by the initial reporter: when supervising student nurse administer fluad influenza vaccine the vaccine leaked from the joint between the syringe and needle and the majority of the patient did not receive the majority of the vaccine.I checked the needle was correctly secured to the syringe post the incident and it was firmly attached.The needle used was a bd eclipse.

Manufacturer Narrative

H.6.Investigation: bd has not been provided photos or samples for catalog 305895 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.Device history record reviews revealed no issued or abnormalities related.

• Brand Name: BD ECLIPSE¿ NEEDLE WITH SLIP-TIP HUB CONFIGURATION
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8897010
• MDR Text Key: 155701394
• Report Number: 3002682307-2019-00452
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K100209
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 305895
• Device Lot Number: 1805012
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other