MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1/2 ML BD SAFETYGLIDE¿ INSULIN SYRINGE W/ ATTACHED NEEDLE; SYRINGE, ANTISTICK

Catalog Number 305934

Device Problem Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 1/2 ml bd safetyglide¿ insulin syringe w/ attached needle was unable to aspirate before use.The following information was provided by the initial reporter: customer reports that it is not possible to aspirate the insulin with the syringe.

• Brand Name: 1/2 ML BD SAFETYGLIDE¿ INSULIN SYRINGE W/ ATTACHED NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9647857
• MDR Text Key: 184524722
• Report Number: 1920898-2020-00057
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 305934
• Device Lot Number: 8211636
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other