MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS; PISTON SYRINGE

Model Number	328466
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	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported syringe 0.5ml 30ga 1/2in uf 10bag 500cs had foreign matter.The following information was provided by the initial reporter: "pharmacist stated, he noticed the clear liquid/foreign matter on needle.".
Event or Problem Description
It was reported syringe 0.5ml 30ga 1/2in uf 10bag 500cs had foreign matter.The following information was provided by the initial reporter: "pharmacist stated, he noticed the clear liquid/foreign matter on needle.".
Additional Manufacturer Narrative
H.6.Investigation: customer returned (6) 1/2cc, 12.7mm, 30g syringes in open poly bags from lot # 1074125.Customer states that there is foreign matter on and coming out of syringe.All returned syringes were examined and 5 out of 6 samples exhibited about 2-3 units of a clear liquid in the barrel.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.A review of the device history record was completed for batch# 1074125.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause: l2l dispatch was opened for excessive silicone being put into the barrels.Several guns had air in the lines.H3 other text : see h.10.

• Brand Name: SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12529288
• Report Number: 1920898-2021-01016
• Device Sequence Number: 17219964
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: 00382908466035
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: Other
• Device Expiration Date: 03/31/2026
• Device Model Number: 328466
• Device Catalogue Number: 328466
• Device Lot Number: 1074125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1