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

Model Number	928856
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	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Investigation summary: 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 manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Investigation conclusion: based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
Event or Problem Description
It was reported that the bd¿ insulin syringe needle contained foreign matter.The following information was provided by the initial reporter: "consumer reported found 1 syringe from this box to have an orange flake on the needle when he removed the needle shield.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 12-apr-2022.Investigation summary: customer returned a single 1ml syringe with no other identification.The syringe needle features a strand of fibrous, plastic-like material roughly 2mm in length.It is orange-colored, matching the needle shield.Additionally, there is a mark on the inside of the needle shield that was made mechanically, though it is deep enough and small enough to be too difficult to properly capture visually.It has been noted that the material was found when the needle shield was first removed, prior to use or potential reshielding by the user.A review of the device history record was completed for batch # 1109065.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Based on the samples received, embecta was able to confirm the customer¿s indicated failure of foreign matter on the syringe needle.The root cause cannot be identified.
Event or Problem Description
It was reported that the bd¿ insulin syringe needle contained foreign matter.The following information was provided by the initial reporter: "consumer reported found 1 syringe from this box to have an orange flake on the needle when he removed the needle shield".

• Brand Name: BD¿ INSULIN SYRINGE
• 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 ; 8015296192
• MDR Report Key: 13905790
• Report Number: 1920898-2022-00194
• Device Sequence Number: 4074884
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 04/30/2026
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: 1109065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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