MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU

Catalog Number 326719

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/05/2020

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 the syringe 1.0ml 29ga 1/2in bls 500 au experienced a breach in sterility which was noted prior to use.The following information was provided by the initial reporter: needle was sticking though orange cap and when health worker picked it up they received a needle stick injury.Needle was sticking though orange cap and the blister pack of the syringe and when health worker picked it up they received a needle stick injury.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/26/2020.H.6.Investigation: customer returned (100) 29gx12.7mm, 1ml bd insulin syringes in sealed blister packs from lot 9140524.Consumer reported needle was sticking though orange cap and when health worker picked it up they received a needle stick injury.All 100 returned syringes were examined, and one was observed with a cannula pierced through the cannula shield; this syringe was inside of a sealed blister pack.A review of the device history record was completed for batch# 9140524.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Process summary: this operation assembles the cannula into the barrel tip and applies adhesive to hold the cannula in the barrel tip.The racks of cannulated barrels then travel through an oven which uses ir light to facilitate adhesive run down and ultraviolet light to cure the adhesive that bonds the cannula to the barrel tip.The cannulated barrels are then conveyed to a machine that inspects for missing cannula, cannula height, point quality, zero line placement, and uv adhesive.It also supplies lube to the cannula, features two lumen blows, assembles the shield to the barrel/cannula assembly, and detects for missing shields.The were no quality notifications or maintenance dispatches relating to this complaint during the production of this batch.A root cause cannot be determined.

Event Description

It was reported that the syringe 1.0ml 29ga 1/2in bls 500 au experienced a breach in sterility which was noted prior to use.The following information was provided by the initial reporter: needle was sticking though orange cap and when health worker picked it up they received a needle stick injury.Needle was sticking though orange cap and the blister pack of the syringe and when health worker picked it up they received a needle stick injury.

• Brand Name: SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9880601
• MDR Text Key: 195116905
• Report Number: 1920898-2020-00309
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326719
• Device Lot Number: 9140524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other