MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ SAFETY SYRINGE

Catalog Number 305934

Device Problem Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 12/08/2018

Event Type  malfunction  

Manufacturer Narrative

(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 bd¿ safety syringe was unable to operate during use.

Manufacturer Narrative

Investigation summary: customer returned (1) loose 1/2cc, 8mm bd safetyglide insulin syringe without any packaging.Customer states that it is unable to take medicine.The returned syringe was tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 8019988.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200736478] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that bd¿ safety syringe was unable to operate during use.

• Brand Name: BD¿ SAFETY SYRINGE
• Type of Device: SAFETY SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8204537
• MDR Text Key: 131775333
• Report Number: 1920898-2018-00987
• Device Sequence Number: 1
• Product Code: MEG
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

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: 305934
• Device Lot Number: 8019988
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other