MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA NO INS; PISTON SYRINGE

Model Number	329408
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 an unspecified number of syringes 0.5ml 31ga no ins experienced a cannula that was too long.The product defect was noted during use.The following information was provided by the initial reporter: material no: 329408 batch no: 8176855 consumer stated, the needles hurt him when he's taking his injection because they are too long.Stated, he would rather use the 6mm instead of 8mm.Consumer stated, he purchased 3 boxes but only opened one box.He does not want to use anymore of the syringes because of the pain he experiences when taking injection.No injury to report.
Additional Manufacturer Narrative
Investigation: no samples (including photos) were returned as of 15 may 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 8176855.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200766920] noted that did not pertain to the complaint.
Event or Problem Description
It was reported that an unspecified number of syringes 0.5ml 31ga no ins experienced a cannula that was too long.The product defect was noted during use.The following information was provided by the initial reporter: material no: 329408 batch no: 8176855.Consumer stated, the needles hurt him when he's taking his injection because they are too long.Stated, he would rather use the 6mm instead of 8mm consumer stated, he purchased 3 boxes but only opened one box.He does not want to use anymore of the syringes because of the pain he experiences when taking injection.No injury to report.

• Brand Name: SYRINGE 0.5ML 31GA NO INS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10027018
• Report Number: 1920898-2020-00475
• Device Sequence Number: 2714979
• Product Code: FMF
• UDI-Device Identifier: 00382903294084
• UDI-Public: 00382903294084
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (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): 05/15/2020

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: 07/31/2023
• Device Model Number: 329408
• Device Catalogue Number: 329408
• Device Lot Number: 8176855
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/15/2020
• 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