MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Model Number 328290

Device Problem Material Puncture/Hole (1504)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported while using bd insulin syringes with bd ultra-fine¿ needle the cannula pierced the shield.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported needle sticking out of needle shield prior to injection stated, could not use syringes.

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 insulin syringes with bd ultra-fine¿ needle the cannula pierced the shield.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported needle sticking out of needle shield prior to injection stated, could not use syringes.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-mar-2023.H6: investigation summary customer returned (2) used 0.5ml syringes inside the metal canister.It was reported by the consumer that needle was sticking out of shield and caused customer to stick their finger.The returned syringes were examined and exhibited the cannula through the shield that could have caused the needle stick.This batch was manufactured in 2015 and files are retained for 7 years, no dhr review can be completed.The hub is cannulated at the needle line on a rack of 25 hubs, during the process the hub & cannula travel through a conveyor system where adhesive is added to bond the cannula to the hub, then travels through a uv oven that has magnetization to aid in cannula angularity.The rack goes through a point inspect machine to kick off all clogged, long, short, double cannula, point defects, insufficient adhesive, & inverted cannula.After point inspect machine the rack travels under a shield station that has a roll over shielder devise that sets the shield on the cannulated hub.No root cause can be determined at this time.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• 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: 16427638
• MDR Text Key: 310248562
• Report Number: 1920898-2023-00065
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282906
• UDI-Public: (01)00382903282906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 328290
• Device Catalogue Number: 328290
• Device Lot Number: 5287666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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