MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326638

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/09/2023

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 while using bd ultra-fine¿ ii 3/10ml insulin syringe the needle pierced the shield.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about needle through shield, causing a needle stick incident.According to the user's report, the needle was piercing through the shield, and the user got stuck with the unused needle upon unpacking.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 21-jun-2023.H6: investigation summary: customer returned (1) 0.3ml 30ga 8mm syringe in a clear ziploc bag.Customer reported that the needle was piercing through the shield, and the user got stuck with the unused needle upon unpacking.The returned syringe was examined and exhibited the cannula through the shield that could lead to needle stick.A review of the device history record was completed for batch #2087442.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to confirm the customer¿s indicated failure.No root cause can be determined at this time.

Event Description

It was reported while using bd ultra-fine¿ ii 3/10ml insulin syringe the needle pierced the shield.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about needle through shield, causing a needle stick incident.According to the user's report, the needle was piercing through the shield, and the user got stuck with the unused needle upon unpacking.

• Brand Name: BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16625173
• MDR Text Key: 312369314
• Report Number: 1920898-2023-00162
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903266388
• UDI-Public: (01)00382903266388
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326638
• Device Lot Number: 2087442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1