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

Catalog Number 328822

Device Problem Volume Accuracy Problem (1675)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported while using bd ultra-fine¿ ii short needle insulin syringe the scale markings were abnormal.This occurred 241 times.The following information was provided by the initial reporter: the complaint is 'the first (zero) scale of the syringe is lower than it should be'.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and one non-conformance was raised in association with this type of event for this lot.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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.A complaint history check was performed and this is the 1st related complaint for scale misaligned on lot # 1228497.A review of risk management (b)(4) indicates that the potential risk of this specific reported incident (syringe, scale misaligned) was captured and addressed.Investigation summary: customer returned (246) loose 3/10cc, 8mm syringes.Customer states that the first (zero) scale of the syringe is lower than it should be.Thirty out of 246 samples were tested using the plug gauge and the placements of all the scale markings fall within specifications.A review of the device history record was completed for batch# 1228497.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There was one (1) notification [(b)(4)] noted for missing 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.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14135079
• MDR Text Key: 289457485
• Report Number: 1920898-2022-00240
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 328822
• Device Lot Number: 1228497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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