MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.5ML 31GX6MM U-100 INSULIN SYRINGE; PISTON SYRINGE

Model Number 328520

Device Problems Volume Accuracy Problem (1675); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and one non-conformance was raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Investigation conclusion: a complaint lot history check was performed on lot # 0013117 for scale marking defective (difficulty understanding scale).This is the 1st related complaint for scale marking defective (difficulty understanding scale) on lot # 0013117.A complaint lot history check was performed on lot # 0013117 for difficult/unable to operate (incorrect dose).This is the 1st related complaint for difficult/unable to operate (incorrect dose) on lot # 0013117.A review of the device history record was completed for batch# 0013117.All inspections and challenges were performed per the applicable operations qc specification.There was one (1) notification [200871302] noted for missing print.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that 0.5ml 31gx6mm u-100 insulin syringe experienced a case of scale marking issues, and under dosage.The following information was provided by the initial reporter: consumer/pet owner reported asking how to read the scale markings on syringe.He checked with the pharmacy first and was misinformed.Pet owner was told first line that is longer and darker than other scale lines, that is also the marker when plunger is pressed completely to the top, is the one unit line and not the zero line.Resulted in giving his dog 2 units instead of 3 as prescribed.Pet owner did not see instructions on the unit line measurements.

• Brand Name: 0.5ML 31GX6MM U-100 INSULIN SYRINGE
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12298923
• MDR Text Key: 265802211
• Report Number: 1920898-2021-00880
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328520
• Device Catalogue Number: 328520
• Device Lot Number: 0013117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1