MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1.0ML 30GA 8MM; PISTON SYRINGE

Model Number	928853
Medical Device Problem Codes	Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
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 bd syringe 1.0ml 30ga 8mm experienced difficult plunger rod movement, and foreign matter in the fluid path.The following information was provided by the initial reporter: consumer reported plunger rod difficult to move.Consumer reported liquid coming from the syringe after depressing the plunger rod.
Event or Problem Description
It was reported that bd syringe 1.0ml 30ga 8mm experienced difficult plunger rod movement, and foreign matter in the fluid path.The following information was provided by the initial reporter: consumer reported plunger rod difficult to move.Consumer reported liquid coming from the syringe after depressing the plunger rod.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-06.Investigation summary: customer returned (1) loose 1cc, 8mm syringe.Customer states that liquid came out of syringe after depressing plunger rod.The returned syringe was examined and exhibited a small amount of 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.Customer returned (1) loose 1cc, 8mm syringe.Customer states that the plunger rod was difficult to move.The returned syringe was tested and the plunger rod was able to be exercised in the barrel without any observed defects.A review of the device history record was completed for batch# 0062649.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure foreign matter.Bd was not able to duplicate or confirm the customer¿s indicated failure plunger rod was difficult to move.The operation assembles the cannula into the barrel tip and applies adhesive to hold the cannula in the barrel tip.The racks of cannulated barrels then travel through an oven which uses ir light to facilitate adhesive run down and ultraviolet light to cure the adhesive that bonds the cannula to the barrel tip.The cannulated barrels are then conveyed to a machine that inspects the missing cannula, cannula height, point quality, zero line placement, and uv adhesive.It also supplies lube to the cannula, features two-lumen blows, assembles the shield to the barrel/cannula assembly, and detects missing shields.The automatic syringe assembly machine feeds 1ml syringe components (barrel, stopper, plunger, and cap) and assembles these components.This machine consists of a barrel-cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspection and transfer dials.There was one (1) notification noted that did not pertain to the complaint.Also, reviewed l2l(leading 2lean) dispatches and maintenance records to investigate for any potential cause.But root cause cannot be determined due to lack of evidence.H3 other text : see h10.

• Brand Name: BD SYRINGE 1.0ML 30GA 8MM
• 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: 13160216
• Report Number: 1920898-2021-01362
• Device Sequence Number: 5766083
• Product Code: FMF
• UDI-Device Identifier: 00311917025292
• UDI-Public: 00311917025292
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 03/31/2025
• Device Model Number: 928853
• Device Catalogue Number: 928853
• Device Lot Number: 0062649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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