MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINEI IV INSULIN SYRINGE; PISTON SYRINGE

Model Number	329424
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is (b)(6) has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd micro-finei¿ iv insulin syringe had scale marking issues.The following information was provided by the initial reporter: "there are ones with no dots, one dot and two dots (same packaging, gauge etc).".
Additional Manufacturer Narrative
H.6.Investigation: customer returned photos of 1cc, 12.7mm, 28g syringes and the associated blister packs.Customer states that they would like to know what the dots mean on each syringe.The photos were examined and exhibited a syringe with 2 dots printed on the barrel near the top of the scale, a syringe with 1 dot printed on the barrel near the top of the scale, and a syringe with no dots printed on the barrel near the top of the scale.As per manufacturing, the number of dots on the syringes corresponds to the impression on the drum, for tracking and analysis of print issues.There can be anywhere from 0-3 dots depending on the line.The samples shown in the photos all fall within specifications.Unable to perform dhr check for scale marking defective due to unknown lot number.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that the bd micro-finei¿ iv insulin syringe had scale marking issues.The following information was provided by the initial reporter: "there are ones with no dots, one dot and two dots (same packaging, gauge etc).".

• Brand Name: BD MICRO-FINEI IV INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11565894
• Report Number: 1920898-2021-00341
• Device Sequence Number: 16882818
• Product Code: FMF
• UDI-Device Identifier: 30382903294245
• UDI-Public: 30382903294245
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• 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): 03/30/2021

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: Health Professional
• Device Model Number: 329424
• Device Catalogue Number: 329424
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1