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

Catalog Number 324912

Device Problems Material Separation (1562); Sticking (1597)

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

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 the needle became stuck in the vial and became separated from the shield when using a bd insulin syringe with the bd ultra-fine¿ needle.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7177600.All inspections were performed per the applicable operations qc specifications.Syringe assembly ¿ there was one (1) batch of material# 700003982 (syringe 1.0ml asm 31ga 6mm sm700177 sc) that went into finished batch# 7177600.Batch# 7177600 date(s) of manufacture: 12aug2017 thru 17aug2017 machine(s) manufactured on: jl, jm, jn, jo pils ¿ there was one (1) batch of material# 700003981 (barrel 1.0ml shd 31ga 6mm sm700177) that went into finished batch# 7177600.Batch# 7177600 date(s) of manufacture: 12aug2017 thru 17aug2017 machine(s) manufactured on: fk there was one (1) notification [200704092] noted for insufficient adhesive.There were six (6) notifications [200704655, 200704654, 200704144, 200704115,200704653, 200704803] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 2nd related complaint for needle separates in vial and the 1st related complaint for needle hub separates on lot # 7177600.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.Based on the above, no additional investigation and no capa is required at this time.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.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7512544
• MDR Text Key: 108241169
• Report Number: 1920898-2018-00315
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: Lay User/Patient
• Device Catalogue Number: 324912
• Device Lot Number: 7177600
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other