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

Catalog Number 328440

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2018

Event Type  malfunction  

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 Description

It was reported that bd insulin syringe with the bd ultra-fine¿ needle scale markings are not aligned.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: customer returned (10) 3/10cc, 8mm, 31g syringes in an open poly bag from lot # 8155819.Customer states that they are finding the markings on the syringe to be off alignment and feels some of the markings on syringe the 0 line is not at the top of syringe.A review of the device history record was completed for batch # 8155819 all inspections were performed per the applicable operations qc specifications.There was one notification [200764831] noted for ink rings.A complaint history check was performed and this is the 1st related complaint for scale misaligned on lot # 8155819.Investigation conclusion: all returned syringes were tested using the plug gauge and all scale marking placements fall within specifications.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.Rationale: 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.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that bd insulin syringe with the bd ultra-fine¿ needle scale markings are not aligned.No serious injury or medical intervention was reported.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8206814
• MDR Text Key: 131782174
• Report Number: 1920898-2018-00986
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908440035
• UDI-Public: 00382908440035
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 328440
• Device Lot Number: 8155819
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other