MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Model Number 324910

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0189393.Medical device expiration date: 2025-07-31.Device manufacture date: 2020-07-07.Medical device lot #: 0363864.Medical device expiration date: 2026-01-31.Device manufacture date: 2020-12-28.Medical device lot #: 1016653.Medical device expiration date: 2026-01-31.Device manufacture date: 2021-01-16.Investigation summary: samples were received and an investigation was performed.A review of the manufacturing records was performed and one non-conformance was raised in association with this type of event for these lots.Bd was not able to duplicate or confirm the indicated issue hence the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion: a complaint history check was performed and this is the 4th related complaint for scale misaligned on lot # 0189393.A complaint history check was performed and this is the 2nd related complaint for scale misaligned on lot # 1016653.A complaint history check was performed and this is the 1st related complaint for scale misaligned on lot # 0363864.A review of the device history record was completed for batch # 0189393 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200905119] noted for scratch print.A review of the device history record was completed for batch # 1016653 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200931339] noted for missing numbers and scale line a review of the device history record was completed for batch # 0363864 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200928490] noted for scratched print.Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause cannot be determined at this time as the issue is unconfirmed.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

It was reported that 450 bd insulin syringe with bd ultra-fine¿ needles experienced scale marking issues.The following information was provided by the initial reporter: the very first scale mark (zero point) is way too lower than it should be and there's about a half unit of extra space.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• 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: 12861151
• MDR Text Key: 284305786
• Report Number: 1920898-2021-01230
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249107
• UDI-Public: 00382903249107
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 324910
• Device Catalogue Number: 324910
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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