MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETY-LOK¿ INSULIN SYRINGE

Catalog Number 329460

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the safety mechanism on a bd safety-lok¿ insulin syringe failed to function properly during use.There was no report of injury or medical interventions.

Manufacturer Narrative

H.6.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 #4176651.All inspections were performed per the applicable operations qc specifications.Syringe assembly ¿ there were 4 batches of material# 8364997 (syringe 1.0ml asm 29ga 1/2in sl sm700167) that went into the finished batch# 4176651.Batch# 4286814.Dates of manufacture: 12nov2014 to 09dec2014.Machines manufactured on: jk.Batch# 4346752.Dates of manufacture: 05jan2015 to 08jan2015.Machines manufactured on: jk.Batch# 4286817.Dates of manufacture: 10dec2014 to 23dec2014.Machines manufactured on: jk.Batch# 4262944.Dates of manufacture: 07oct2014 to 19oct2014.Machines manufactured on: jk.There were two (2) notifications [200570419, 200561806] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for difficult to operate safety mechanism on lot # 4176651.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 SAFETY-LOK¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7515362
• MDR Text Key: 108498854
• Report Number: 1920898-2018-00323
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 329460
• Device Lot Number: 4176651
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other