MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL; PISTON SYRINGE

Catalog Number 328506

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that four syringes 1.0 ml 31ga 8 mm 10bag 500 wal caused an allergic reaction after use.The following information was provided by the initial reporter: material no.: 328506.Batch no.: 8190574.Complaint 2 of 2: date of occurrence (b)(6) 2019.Verbatim: consumer stated: after injection in both her left and right thigh, she noticed "red streaks" that later became "warm" to the touch and "itchy".It happened on (b)(6) 2019.4 syringes were used.No medication or follow up visits necessary and she wipes the needle with a alcohol swab before use.Stated once the itching stops and redness goes away, a bruise is left behind.

Event Description

It was reported that four syringes 1.0ml 31ga 8mm 10bag 500 wal caused an allergic reaction after use.The following information was provided by the initial reporter: material no.: 328506 batch no.: 8190574 complaint 2 of 2: date of occurrence 27-jun-2019.Verbatim: consumer stated: after injection in both her left and right thigh, she noticed "red streaks" that later became "warm" to the touch and "itchy".It happened on 06/27/19.4 syringes were used.No medication or follow up visits necessary and she wipes the needle with a alcohol swab before use.Stated once the itching stops and redness goes away, a bruise is left behind.

Manufacturer Narrative

H.6.Investigation: customer returned (20) 1cc, 8mm, 31g relion syringes (10 loose, 10 in a sealed poly bag) from lot # 8190574.Customer states that after injection in both her left and right thigh, she noticed "red streaks" that later became "warm" to the touch and "itchy".All returned syringes were tested 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# 8190574.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8787180
• MDR Text Key: 150990261
• Report Number: 1920898-2019-00659
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328506
• Device Lot Number: 8190574
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other