MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA; PISTON SYRINGE

Catalog Number	329416
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
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 plunger error occurred during use with a syringe 1.0ml 31ga no ins.The following information was provided by the initial reporter, "consumer reported he cannot draw the insulin his syringe.He cannot pull back the plunger and nothing comes in the barrel.He uses the new syringes each time of his injection.He pulls the right amount of air in before drawing syringes." 4 occurrences were reported.
Additional Manufacturer Narrative
Investigation: customer returned one (1) loose 31g x 8mm, 1ml bd insulin syringes.Consumer reported he cannot draw the insulin his syringe; he cannot pull back the plunger and nothing comes in the barrel.The returned sample was examined, and no apparent issues were observed.The syringe was tested for plunger rod movement: no issues were observed.Then, the syringe was tested for flow using water: the syringe was able to draw and expel properly.As no manufacturing defects were observed, the alleged issues could not be confirmed.A review of the device history record was completed for batch# 8267533.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issues are unconfirmed.
Event or Problem Description
It was reported that plunger error occurred during use with a syringe 1.0ml 31ga no ins.The following information was provided by the initial reporter, "consumer reported he cannot draw the insulin his syringe.He cannot pull back the plunger and nothing comes in the barrel.He uses the new syringes each time of his injection.He pulls the right amount of air in before drawing syringes." 4 occurrences were reported.

• Brand Name: SYRINGE 1.0ML 31GA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8922019
• Report Number: 1920898-2019-00860
• Device Sequence Number: 11314374
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 329416
• Device Lot Number: 8267533
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other