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

Catalog Number 928856

Device Problem Bent (1059)

Patient Problem Numbness (2415)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 by a consumer that the barrels on bd¿ insulin syringe with needles were found bent making it difficult to obtain volume accuracy.In addition, the customer stated the plunger makes the insulin black which could indicate foreign matter.It was also reported the customer stated there was "numbness in the arm, throat feels like its closing and a funny taste in the mouth like perfume." there was no report of exposure 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.A review of the device history record was completed for batch# 7240676.All inspections were performed per the applicable operations qc specifications.Syringe assembly ¿ there were two batches of material# 8359163 (syringe 1.0ml asm 31ga 8mm sm700151) that went into finished batch# 7240676.Batch# 7268966.Date(s) of manufacture: 27oct2017 thru 29oct2017.Machine(s) manufactured on: jl, jm, jn, jo.Batch# 7240676.Date(s) of manufacture: 25oct2017 thru 27oct2017.Machine(s) manufactured on: jl, jm, jn, jo.There were five notifications [200715205, 200714900, 200714982, 200715371, 200716367] noted that did not pertain to the complaint.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for foreign matter, the 1st related complaint for barrel is bent and the 1st related complaint for allergic reaction on lot # 7240676.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 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: 7410987
• MDR Text Key: 104828184
• Report Number: 1920898-2018-00192
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 928856
• Device Lot Number: 7240676
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other