MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928858
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	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 0.3ml 31ga 8mm 10bag 500 pl/wg had foreign matter in the syringe.The following information was provided by the initial reporter: material no: 928858 batch no: 0174605 ¿ it was reported that a consumer reported seeing clear liquid in syringe prior to use.¿ verbatim: (b)(6) consumer reported seeing clear liquid in syringe prior to use.Stated, she pushed on the plunger rod and clear liquid.Stated, doesn't feel comfortable continuing to use them.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-18.H6: investigation summary customer returned (20) 3/10cc, 8mm, 31g walgreens syringes in sealed poly bags from lot # 0174605.Customer states that they are seeing clear liquid in syringe prior to use pushing on the plunger rod.All returned syringes were tested and 5 out of 20 samples exhibited a small clear droplet of material coming out of the cannula when the plunger rod was fully depressed.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 polypropylene.A review of the device history record was completed for batch # 0174605 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause: maintenance dispatch (l2l) #107887 was created on 16oct2020 for excessive silicone dispensed into the barrels.
Event or Problem Description
It was reported that syringe 0.3ml 31ga 8mm 10bag 500 pl/wg had foreign matter in the syringe.The following information was provided by the initial reporter: material no: 928858 batch no: 0174605.  it was reported that a consumer reported seeing clear liquid in syringe prior to use.  verbatim: walgreens consumer reported seeing clear liquid in syringe prior to use.Stated, she pushed on the plunger rod and clear liquid.Stated, doesn't feel comfortable continuing to use them.

• Brand Name: SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11566204
• Report Number: 1920898-2021-00343
• Device Sequence Number: 11501868
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: Lay User/Patient
• Device Expiration Date: 06/30/2025
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: 0174605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1