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

Catalog Number 328438

Device Problem Positioning Failure (1158)

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

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: a complaint history check was performed and this is the 1st related complaint for difficult to operate, needle pain and needle dull on lot # 7306563.Customer returned (4) loose 3/10cc, 8mm, 31g syringes.Customer states that the syringes are jamming and sticky and the needles are dull and painful.All returned syringes were tested and all were able to draw and expel properly without any observed defects.All samples were also tested for point geometry, lube, and cannula od.All observations fall within specifications.A review of the device history record was completed for batch # 7306563 all inspections were performed per the applicable operations qc specifications.There were three (3) notifications [(b)(4)] noted that did not pertain to the complaint.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.Investigation conclusion: 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 description: root cause cannot be determined at this time as the issue is unconfirmed.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle is difficult to operate or restricted movement.No serious injury or medical intervention was reported.

Manufacturer Narrative

Customer returned (4) loose 3/10cc, 8mm, 31g syringes.Customer states that the syringes are jamming and sticky and the needles are dull and painful.All returned syringes were tested and all were able to draw and expel properly without any observed defects.All samples were also tested for point geometry, lube, and cannula od.The following was observed (specs: outer diameter for 31g: 0.0100¿-0.0105¿): (b)(6).All observations fall within specifications.A review of the device history record was completed for batch # 7306563 all inspections were performed per the applicable operations qc specifications.There were three (3) notifications (b)(4) noted that did not pertain to the complaint.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle is difficult to operate or restricted movement.No serious injury or medical intervention was reported.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8048804
• MDR Text Key: 128047769
• Report Number: 1920898-2018-00836
• Device Sequence Number: 0
• Product Code: FMF
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 328438
• Device Lot Number: 7306563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other