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

Catalog Number 305934

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Event Description

It was reported that the 1/2 ml bd safetyglide¿ insulin syringe with attached needle experienced device damage while still considered operable.The following information was provided by the initial reporter: broken barrel.

Manufacturer Narrative

Date of event: unknown.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

• Brand Name: 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12610367
• MDR Text Key: 282110663
• Report Number: 1920898-2021-01064
• 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
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1