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

Catalog Number 328440

Device Problems Volume Accuracy Problem (1675); Material Twisted/Bent (2981)

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

Event Date 10/27/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd insulin syringe with the bd ultra-fine¿ needle there was an issue with barrel bent/volumetric inaccuracy.There was no report of injury or medical intervention.

Manufacturer Narrative

Customer returned (1) loose 3/10cc, 8mm syringe.Customer states that the barrel was bent.The returned syringe was examined and exhibited a deformed barrel.Upon evaluation by (b)(4), similar findings to those documented during initial investigation performed at (b)(4) were noted.The returned sample was visually inspected and was noted to have an s-shaped bend at approximately the 30u (30 units) scale marking of the syringe.Damage to the exterior of the syringe barrel was noted from about 28u and beyond and extended through the width of the syringe barrel, including the plunger rod.Given this, the damage occurred after full assembly of the device on the metro (assembly equipment).The returned sample was reviewed with a process sme (subject-matter expert) and probable root cause was determined to likely be a jaw jam on the form fill & seal (ffs) operation.When this type of event occurs, any portion of the syringe and/or component may be involved in the jam and exhibit varying degrees of damage, such as is noted with the returned sample.Generally, the device is rendered inoperable by the end-user.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 that did not pertain to the complaint.Based on the samples/photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (deformed barrel).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 capa is required at this time.Possible root cause: molding - processing issue (parts were blocked and associate didn't back off the plastic infeed, water problems, overpacking, etc.).Material handling (duration of components being stored in totes).

Event Description

It was reported with the use of the bd insulin syringe with the bd ultra-fine needle there was an issue with barrel bent/volumetric inaccuracy.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.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 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 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.

Event Description

It was reported with the use of the bd insulin syringe with the bd ultra-fine¿ needle there was an issue with barrel bent/volumetric inaccuracy.There was no report of injury or medical intervention.

• 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: 8065642
• MDR Text Key: 127071989
• Report Number: 1920898-2018-00873
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 328440
• Device Lot Number: 8155819
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other