MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS; PISTON SYRINGE

Model Number	328431
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
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 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 an unspecified number of syringe 0.3ml 30ga 1/2in uf 10bag 500cs had missing scale markings before use.The following was reported by the initial reporter: "it was reported the unit marking unusable on a few of the syringes.Verbatim: email:hi i'm a type 1 diabetic and i have used your bd syringes for years.I found an issue with a few syringes with the unit marking unusable on a few of the syringes.Just wanted to let you know.· product name and/or catalog number - bd insulin syringes 3/10 ml 12.7mm / 30g ( ultrafine)· lot number or serial number - (b)(4)· any injuries and/or harm? - no· what is the issue you experienced? - the insulin syringes did not have markings usable for drawing the correct amount ( of insulin).I'll attach pics.· is the actual sample or sample representative available? (if possible, please send affected sample) - i saved one for you if needed.Thanks for your assistance with this!".
Event or Problem Description
It was reported that an unspecified number of syringe 0.3ml 30ga 1/2in uf 10bag 500cs had missing scale markings before use.The following was reported by the initial reporter: "it was reported the unit marking unusable on a few of the syringes.Verbatim: email:hi i'm a type 1 diabetic and i have used your bd syringes for years.I found an issue with a few syringes with the unit marking unusable on a few of the syringes.Just wanted to let you know.Product name and/or catalog number - bd insulin syringes 3/10 ml 12.7mm / 30g ( ultrafine) lot number or serial number - 0111971 any injuries and/or harm? - no.What is the issue you experienced? - the insulin syringes did not have markings usable for drawing the correct amount ( of insulin).I'll attach pics.Is the actual sample or sample representative available? (if possible, please send affected sample) - i saved one for you if needed.Thanks for your assistance with this!".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/18/2021.H.6.Investigation: customer returned a single syringe with no pouch.A visual inspection found that the barrel of the syringe does not have the standard graduation markings.There are no markings on the barrel outside of a black smudge streak toward the middle of the barrel.A review of the device history record was completed for batch# 0111971.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.Root cause: a doctor blade is used in the printing process to ¿scrape¿ the ink off the barrel after application of ink.The doctor blade was not set seated fully on the shaft causing the doctor blade to remove most all of the ink on the barrel.H3 other text : see h.10.

• Brand Name: SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11606035
• Report Number: 1920898-2021-00376
• Device Sequence Number: 4206417
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 04/30/2025
• Device Model Number: 328431
• Device Catalogue Number: 328431
• Device Lot Number: 0111971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1