MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD MICRO-FINE IV NEEDLE; PISTON SYRINGE

Model Number	329461
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	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that 5 boxes of bd insulin syringes with the bd micro-fine¿ iv needle had foreign liquid found inside the syringe barrels.The following information was provided by the initial reporter: "the end user has started using the syringes and noted that approximately 40% of the syringes have an unidentified liquid in the syringe.All five boxes have this issue.".
Event or Problem Description
It was reported that 5 boxes of bd insulin syringes with the bd micro-fine¿ iv needle had foreign liquid found inside the syringe barrels.The following information was provided by the initial reporter: "the end user has started using the syringes and noted that approximately 40% of the syringes have an unidentified liquid in the syringe.All five boxes have this issue.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 6/9/2021.H6: investigation: customer returned (5) loose 1/2cc, 12.7mm syringes.Customer states that the syringes have an unidentified liquid in the syringe.All returned syringes were tested and all exhibited a clear droplet of material coming out of the barrel 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 silicone.A review of the device history record was completed for batch# 0132264.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.There was one (1) notification noted for excessive silicone.Corrective action: replaced silicone gun #7.Visually inspected 100 parts finding 0 defects prior to machine start up.The affected product was scrapped.

• Brand Name: BD INSULIN SYRINGE WITH THE BD MICRO-FINE IV NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11949844
• Report Number: 1920898-2021-00641
• Device Sequence Number: 16408777
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 07/31/2025
• Device Model Number: 329461
• Device Catalogue Number: 329461
• Device Lot Number: 0132264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1