MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE INSULIN SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number 305934

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

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.(b)(4).

Event Description

It was reported during use the bd safetyglide¿ insulin syringe with needle was unable or difficult to aspirate.The following information was provided by the initial reporter: the customer stated "the syringe does not aspirate.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 8211636.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h.10.

Event Description

It was reported during use the bd safetyglide¿ insulin syringe with needle was unable or difficult to aspirate.The following information was provided by the initial reporter: the customer stated "the syringe does not aspirate.".

• Brand Name: BD SAFETYGLIDE INSULIN SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10519063
• MDR Text Key: 208402010
• Report Number: 1920898-2020-01198
• 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: 09/22/2020

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: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 305934
• Device Lot Number: 8211636
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other