MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 305950

Device Problems Detachment Of Device Component (1104); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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, a allergist tray bd safetyglide needle malfunctioned as ¿the plunger separated from the stopper, the stopper froze and would not dispense the medication." there was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: one (1) loose 1cc syringe without any packaging of the shield was returned with the safety mechanism activated.It was reported that the plunger separated from the stopper and the stopper froze and would not dispense the medication.The returned syringe was tested and the stopper separated from the plunger rod when attempting to draw the plunger back.No damage to the plunger rod was observed.The stopper was observed to be fully depressed in the barrel.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (stopper separates from plunger rod).Investigation conclusion: insufficient silicone in the barrel.Based on the investigation, no capa is required at this time.

• Brand Name: ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7274181
• MDR Text Key: 100444841
• Report Number: 1920898-2018-00092
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059509
• UDI-Public: 30382903059509
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 305950
• Device Lot Number: 6298706
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other