MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE; PISTON SYRINGE

Model Number	TRANSFUSION
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: no samples 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# 9070601.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There was one (1) notification [200812519] noted that did not pertain to the complaint.Occurrence: a complaint history check was performed and this is the 1st related complaint for barrel discolored on lot # 9070601.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, barrel discolored) was captured and addressed appropriately.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the bd¿ insulin syringe was "dark" up to the 5 unit mark.This was noticed during use.The following information was provided by the initial reporter: "consumer left voicemail stating that the syringes are dark.I returned consumer's call, she stated that a section of the syringes are dark up to the 5 unit mark.Consumer said she noticed it about one week ago, alos said she does not re-use.".

• Brand Name: BD INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10156239
• Report Number: 1920898-2020-00678
• Device Sequence Number: 2850330
• Product Code: FMF
• UDI-Device Identifier: 10885403421532
• UDI-Public: 10885403421532
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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 Expiration Date: 03/31/2024
• Device Model Number: TRANSFUSION
• Device Catalogue Number: 324906
• Device Lot Number: 9070601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other