MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Catalog Number 928858

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348); Needle Stick/Puncture (2462)

Event Date 07/25/2019

Event Type  Injury  

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 consumer sustained a needle stick injury from the syringe 0.3ml 31ga 8mm 10bag 500 pl/wg during use while attempting to reshield the needle after having given her pet an injection.No medical intervention was reported, and the consumer reportedly "does not plan" on seeking it out.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: pet owner reported sticking her finger when she re-shield after giving pet injection.Stated: did not know she should not re-shield.Stated: there was bleeding but it stopped soon after.No medical attention received.Does not plan on seeking medical or re-shielding going forward.Lot: 8232713, expiration date: 08/2023, incident occurred this morning, (b)(6) 2019.Stated she has stuck herself a couple of times in past but does not have specific date or lot to provide.

Event Description

It was reported that the consumer sustained a needle stick injury from the syringe 0.3ml 31ga 8mm 10bag 500 pl/wg during use while attempting to reshield the needle after having given her pet an injection.No medical intervention was reported, and the consumer reportedly "does not plan" on seeking it out.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: pet owner reported sticking her finger when she re-shield after giving pet injection.Stated: did not know she should not re-shield stated: there was bleeding but it stopped soon after.No medical attention received.Does not plan on seeking medical or re-shielding going forward.Lot: 8232713 expiration date: 2023-08 incident occurred this morning, (b)(6) 2019 stated she has stuck herself a couple of times in past but does not have specific date or lot to provide.

Manufacturer Narrative

Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 8232713.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications [(b)(4)] noted that did not pertain to the complaint.

• Brand Name: SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8879061
• MDR Text Key: 153839562
• Report Number: 1920898-2019-00786
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 928858
• Device Lot Number: 8232713
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other