MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500; PISTON SYRINGE

Catalog Number 328440

Device Problem Defective Device (2588)

Patient Problems Itching Sensation (1943); Reaction, Injection Site (2442); Skin Inflammation (2443)

Event Date 07/23/2019

Event Type  malfunction  

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.

Event Description

It was reported that the syringe 0.3 ml 31ga 8 mm half unit 10bg 500 experienced product damage with the device still considered operable.Product defect was noted after use.The following information was provided by the initial reporter: material no.328440, batch no.Unknown.Verbatim: consumer getting red marks at injection site never seen this before this box--- evaluation results request.Consumer using a new needle with each injection.Wipes site down with alcohol.Diabetic injecting with bd for 39 years.Using syringes with insulin 3 units twice a day.Found in the past few days on her injection site left hip her 8 sites with red marks that itch.This morning 7/23/2019 used her right hip and same happened.Got a red mark.Some other needles feel point damaged.No known allergies to anything or metals.Found after injection.No medical appointments made for this incident at this time.Takes the syringes out of box and bags keeps them in a zip lock bag for traveling use.Always using the same size syringe of bd.Denied reuse.

Manufacturer Narrative

H.6.Investigation: customer returned (11) 3/10cc, 8mm, 31g syringes (1 loose, 10 in a sealed poly bag) from lot#: 8260803.Customer states that after the injection there are red marks that itch and the needle point is damaged.All returned syringes were tested (#1 loose, #2-11 from the sealed poly bag) for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).All observations fall within specifications.A review of the device history record was completed for batch#: 8260803 all inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200779743, 200779545] noted that did not pertain to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.

Event Description

It was reported that the syringe 0.3ml 31ga 8mm halfunit 10bg 500 experienced product damage with the device still considered operable.Product defect was noted after use.The following information was provided by the initial reporter: material no: 328440, batch no: unknown.Consumer getting red marks at injection site never seen this before this box.Evaluation results request.Consumer using a new needle with each injection.Wipes site down with alcohol.Diabetic injecting with bd for 39 years.Using syringes with insulin 3 units twice a day.Found in the past few days on her injection site left hip her 8 sites with red marks that itch.This morning on (b)(6) 2019 used her right hip and same happened.Got a red mark.Some other needles feel point damaged.No known allergies to anything or metals.Found after injection.No medical appointments made for this incident at this time.Takes the syringes out of box and bags keeps them in a zip lock bag for traveling use.Always using the same size syringe of bd.Denied reuse.

• Brand Name: SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8872072
• MDR Text Key: 153814504
• Report Number: 1920898-2019-00771
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908440035
• UDI-Public: 00382908440035
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328440
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other