MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE II INSULIN SYRINGE

Catalog Number 328325

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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.(b)(4).

Event Description

It was reported that the bd ultra-fine¿ ii insulin syringe experienced the cannula piercing through the shield.The following information was provided by the initial reporter: consumer purchased 1 pack of 10 ultra fine ii syringes, lot#: 9112567.A syringe came defective: the needle must have bent in the machine that puts the orange shield on, and pierced the shield and was exposed.When he took it out of the package, he pricked his finger.

Event Description

It was reported that the bd ultra-fine¿ ii insulin syringe experienced the cannula piercing through the shield.The following information was provided by the initial reporter: consumer purchased 1 pack of 10 ultra fine ii syringes, lot: 9112567.A syringe came defective: the needle must have bent in the machine that puts the orange shield on and pierced the shield and was exposed.When he took it out of the package, he pricked his finger.

Manufacturer Narrative

H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.5 photos of (1) loose 0.5ml bd insulin syringe were provided.The customer reported that the needle must have bent in the machine that puts the orange shield on, that the needle pierced the shield and was exposed and that when he took the syringe out of the package he pricked his finger.The photos were reviewed, and it was observed that the cannula was pierced through the cannula shield, which could lead to a needle stick.A review of the device history record was completed for batch#: 9112567.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertain to the complaint.Root cause cannot be determined.

• Brand Name: BD ULTRA-FINE II INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11052677
• MDR Text Key: 223180572
• Report Number: 1920898-2020-01733
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 328325
• Device Lot Number: 9112567
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1