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

Model Number 328440

Device Problem Failure to Deliver (2338)

Patient Problems Bruise/Contusion (1754); Overdose (1988); Pain (1994)

Event Date 12/31/2019

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 an unspecified number of syringes 0.3ml 31ga 8mm halfunit 10bg 500 experienced under or over dosage during use.The following information was provided by the initial reporter: material no: 328440, batch no: 9161989.Verbatim: consumer reported painful injections with this batch.Stated, its difficult to push the needles into her injection site.Stated, she's not getting a smooth injection like she normally does.Stated, not sure if she got all her insulin from shot this morning.Stated, with the shot today, she was not sure if she got all her insulin, (this is the only day she's questioning if she got complete dosage) (b)(6) 2019.Stated, she's used two bags so far from this box she's reporting.Stated, using bd products for decades and never had issue.Stated, she does experience pain and bruising with every shot so far from this box but it goes away.Has not seen a doctor and does not plan on seeing a doctor.Lot: 9161989, item: 328440, expiration date: 2024-06-30.Samples available.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned as of (b)(6) 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9161989.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

Event Description

It was reported that an unspecified number of syringes 0.3ml 31ga 8mm halfunit 10bg 500 experienced under or over dosage during use.The following information was provided by the initial reporter: material no: 328440 batch no: 9161989 verbatim: consumer reported painful injections with this batch stated, its difficult to push the needles into her injection site stated, she's not getting a smooth injection like she normally does stated, not sure if she got all her insulin from shot this morning.Stated, with the shot today, she was not sure if she got all her insulin, (this is the only day she's questioning if she got complete dosage) (b)(6) 2019 stated, she's used two bags so far from this box she's reporting stated, using bd products for decades and never had issue stated, she does experience pain and bruising with every shot so far from this box but it goes away.Has not seen a doctor and does not plan on seeing a doctor.Lot: 9161989 item: 328440 expiration date: 2024-06-30.Samples available.

Manufacturer Narrative

H.6.Investigation: customer returned (20) loose 3/10cc, 8mm, 31g syringes.Customer states that there are painful injections, it¿s difficult to push the needles into her injection site, she is not sure if she got all her insulin, and there is bruising.All returned syringes were tested point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).Five out of 20 samples exhibited a hooked cannula point.All samples were also tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 9161989.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure(hooked point).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (difficult to operate).Hooked point caused by customer during use of the product.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of syringes 0.3ml 31ga 8mm halfunit 10bg 500 experienced under or over dosage during use.The following information was provided by the initial reporter: material no: 328440; batch no: 9161989.Verbatim: consumer reported painful injections with this batch.Stated, its difficult to push the needles into her injection site.Stated, she's not getting a smooth injection like she normally does.Stated, not sure if she got all her insulin from shot this morning.Stated, with the shot today, she was not sure if she got all her insulin, (this is the only day she's questioning if she got complete dosage) (b)(6) 2019.Stated, she's used two bags so far from this box she's reporting.Stated, using bd products for decades and never had issue.Stated, she does experience pain and bruising with every shot so far from this box but it goes away.Has not seen a doctor and does not plan on seeing a doctor.Lot: 9161989; item: 328440; expiration date: 2024-06-30; samples available.

• 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: 9594346
• MDR Text Key: 180713824
• Report Number: 1920898-2020-00008
• 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,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328440
• Device Catalogue Number: 328440
• Device Lot Number: 9161989
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other