MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29 G X 1/2 IN. BD¿ NEEDLE; SAFETY ENGINEERED INSULIN SYRINGE AND NEEDLE

Catalog Number 305930

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).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 with use, a bd safety glide¿ insulin syringe with bd¿ permanently attached needle malfunctioned as ¿the plunger got disconnected from the main body of the syringe." there was no report of injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: customer returned (1) bd 1ml, 13mm, 29g safetyglide insulin syringe in an open blister pack from lot # 6315757, cat # 305930.Customer states that the plunger disassembles from the body of the syringe.The returned syringe was tested and the stopper separated from the plunger rod when attempting to draw the plunger rod back.No damage to the plunger rod was observed.As per manufacturing, a review of the device history record was completed for batch# 6315757.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200676963] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure based on the above, no additional investigation and no capa is required at this time investigation conclusion: possible root cause: insufficient silicone in the barrel.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29 G X 1/2 IN. BD¿ NEEDLE
• Type of Device: SAFETY ENGINEERED INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7307882
• MDR Text Key: 101482132
• Report Number: 1920898-2018-00099
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 305930
• Device Lot Number: 6315757
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other