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

Model Number 328438

Device Problems Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

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 fda device problem code(s): 2979, 1504.Fda patient problem code(s): 2462.

Event Description

It was reported that an unspecified number of bd insulin syringe with bd ultra-fine¿ needle experienced product damage while still considered operable during use.The product defect resulted in a needle stick injury to the device operator.It has not been specified whether any medical intervention/testing was administered as a result.The following information was provided by the initial reporter: material no: 328438 batch no: unknown (provided 0041302) after administering epoetin alfa on another individual i went to replace the orange cap on the needle.The tip of the needle went through the orange cap and pricked my finger.

Manufacturer Narrative

H.6.Investigation: no samples were returned as of 19 october 2020 therefore the investigation was performed based on the photos provided.Four (4) photos of a 0.3ml syringe were provided.Consumer reported went to replace the orange cap on the needle, and the tip of the needle went through the orange cap and pricked my finger.The provided photos were reviewed, and it was observed that the cannula on a used syringe had pierced through the cannula shield.No evidence of manufacturing defect could be determined from the photos provided.Since the syringe was captured after use, and no manufacturing defects were observed, the probable cause of the cannula through shield is user error: if the user removes or reattaches the cannula shield obliquely they may bend the cannula and potentially cause the cannula to pierce the shield.Unable to perform complaint a dhr review for cannula through shield and needle stick (after use) due to unknown lot number.

Event Description

It was reported that an unspecified number of bd insulin syringe with bd ultra-fine¿ needle experienced product damage while still considered operable during use.The product defect resulted in a needle stick injury to the device operator.It has not been specified whether any medical intervention/testing was administered as a result.The following information was provided by the initial reporter: material no: 328438 batch no: unknown (provided 0041302).After administering epoetin alfa on another individual i went to replace the orange cap on the needle.The tip of the needle went through the orange cap and pricked my finger.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10570838
• MDR Text Key: 208088528
• Report Number: 1920898-2020-01283
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328438
• Device Catalogue Number: 328438
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other