MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 2 BD SYRINGE 0.5ML 31G 6MM S/C U-100 RELION; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328520
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that liquid comes out of the 2 bd syringe 0.5ml 31g 6mm s/c u-100 relion when plunger is moved.The following information was provided by the initial reporter: consumer reported finding in all packets 3-6 syringes liquid comes out of needle when plunger is moved.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2087334, medical device expiration date: 30-apr-2027, device manufacture date: 28-mar-2022, medical device lot #: unknown , medical device expiration date: unknown, device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-feb-2023.H6: investigation summary; customer returned (2) 0.5ml insulin syringes in an open polybag from lot# 2087334.The customer reported liquid coming out of the needle when the plunger is moved.The samples were examined, then tested for plunger rod movement.No liquid dispensed from either cannula as the plunger rods were exercised or fully depressed.The alleged issue could not be confirmed based on the samples returned for investigation.A review of the device history record was completed for batch# 2087334.All inspections and challenges were performed per the applicable operations qc specifications.Embecta 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.H3 other text : see h10.
Event or Problem Description
It was reported that liquid comes out of the 2 bd syringe 0.5ml 31g 6mm s/c u-100 relion when plunger is moved.The following information was provided by the initial reporter: consumer reported finding in all packets 3-6 syringes liquid comes out of needle when plunger is moved.
Additional Manufacturer Narrative
Investigation summary 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# 2087334.All inspections and challenges were performed per the applicable operations qc specification.
Event or Problem Description
It was reported that liquid comes out of the 2 bd syringe 0.5ml 31g 6mm s/c u-100 relion when plunger is moved.The following information was provided by the initial reporter: consumer reported finding in all packets 3-6 syringes liquid comes out of needle when plunger is moved.

• Brand Name: 2 BD SYRINGE 0.5ML 31G 6MM S/C U-100 RELION
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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 ; 8015296192
• MDR Report Key: 15432731
• Report Number: 1920898-2022-00621
• Device Sequence Number: 12221367
• Product Code: FMI
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2023

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: 328520
• Device Catalogue Number: 328520
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 03/01/2023
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/01/2022; 03/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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