MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Model Number	328519
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle the barrel was cracked and insulin leaked from the barrel.The following information was provided by the initial reporter: it was reported by the consumer when she drew up the insulin and prepared to give herself the injection, insulin leaked from the barrel.Stated, there were "holes" or "cracks" in barrel prior to injection the following information was provided by the initial reporter: consumer reported, when she drew up the insulin and prepared to give herself the injection, insulin leaked from the barrel.Stated, there were "holes" or "cracks" in barrel prior to injection.1 syringe affected, lot: 2255901, catalog: 328519, date of event: unknown, sample: yes (b)(6).Product name: syr 1.0ml 31g 6, lot number(s) and/or serial number(s): (b)(6), material/catalog number: 328519, quantity involved: 1, contaminated: no, used product to be returned for evaluation: yes, how many units?: 1, is country event occurred unknown: no, country event occurred: united states of america, representative samples?: no, current location of device: end user, replacement or credits for affected devices?: replacement, bd awareness date: 2023-05-02, complaint date received: 2023-05-02, how often has the defect occurred?: once.Adverse events: when did the incident occur?: during use, death?: no, serious injury: no, erroneous results: no, course treatment changed due to event: no, exposure to blood/bodily fluid: no, medical intervention other than first aid: no, needle/probe stick: no, safety issue: no, other actions taken: no.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H6: investigation summary no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.Review of the device history record was completed for batch# 2255901.All inspections and challenges were performed per the applicable operations qc specification.H3 other text: see h10.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-jun-2023.H6: investigation summary: customer returned (1) 1.0ml 31g 6mm syringe in an open polybag from the lot# 2255901.It was reported that syringe leaked and barrel cracked.Returned sample visually examined and observed barrel crack.Functionality test has been performed and observed leakage due to crack on the barrel.A review of the device history record was completed for batch # 2255901.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to confirm the customer indicated failure.Root cause for the leakage is due to barrel crack.H3 other text : see h10.
Event or Problem Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle the barrel was cracked and insulin leaked from the barrel.The following information was provided by the initial reporter: it was reported by the consumer when she drew up the insulin and prepared to give herself the injection, insulin leaked from the barrel.Stated, there were "holes" or "cracks" in barrel prior to injection the following information was provided by the initial reporter: consumer reported, when she drew up the insulin and prepared to give herself the injection, insulin leaked from the barrel.Stated, there were "holes" or "cracks" in barrel prior to injection 1 syringe affected lot: 2255901.Catalog: 328519.Date of event: unknown.Sample: yes cl.Product name: syr 1.0ml 31g 6.Lot number(s) and/or serial number(s): 2255901.Material/catalog number: 328519.Quantity involved: 1.Contaminated: no.Used product to be returned for evaluation: yes.How many units?: 1.Is country event occurred unknown: no.Country event occurred: united states of america.Representative samples?: no.Current location of device: end user.Replacement or credits for affected devices?: replacement.Bd awareness date: 2023-05-02.Complaint date received: 2023-05-02.How often has the defect occurred?: once.Adverse events: when did the incident occur?: during use.Death?: no.Serious injury: no.Erroneous results: no.Course treatment changed due to event: no.Exposure to blood/bodily fluid: no.Medical intervention other than first aid: no.Needle/probe stick: no.Safety issue: no.Other actions taken: no.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17011068
• Report Number: 1920898-2023-00314
• Device Sequence Number: 6975899
• Product Code: FMI
• UDI-Device Identifier: 00681131138345
• UDI-Public: (01)00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 2255901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 08/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown