MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE ALLERGIST TRAY WITH BD SAFETYGLIDE¿ PERMANENTLY ATTACHED, REGULAR BEVEL NEEDLE; PISTON SYRINGE

Catalog Number 305950

Device Problem Material Separation (1562)

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

Event Date 11/06/2018

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 the syringes in the allergist tray with bd safetyglide¿ permanently attached, regular bevel needle were "falling apart".

Manufacturer Narrative

Investigation: customer returned (100) 1ml, 13mm, 27g bd safetyglide allergy syringes in sealed trays from lot # 8015605.Customer states that the syringes are falling apart.Thirty out of 100 returned syringes were tested and all samples were able to draw and expel properly and be activated properly without any observed defects.Bd was not able to duplicate or confirm the customer¿s indicated failure.A review of the device history record was completed for batch# 8015605.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that the syringes in the allergist tray with bd safetyglide¿ permanently attached, regular bevel needle were "falling apart".

• Brand Name: ALLERGIST TRAY WITH BD SAFETYGLIDE¿ PERMANENTLY ATTACHED, REGULAR BEVEL NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8095740
• MDR Text Key: 128195589
• Report Number: 1920898-2018-00895
• Device Sequence Number: 1
• Product Code: MEG
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 305950
• Device Lot Number: 8015605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 11/06/2018
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other