MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE 0.3ML 31GX5/16"; INSULIN SYRINGE AND NEEDLE

Catalog Number 328440

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.Medical device expiration date: this device does not have an expiration date.(b)(4).Device evaluation: a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported the shield of several syringes was hard to remove and felt tighter than normal.The customer removed the shield with his teeth, jabbing his finger on the unused needle in the process.Although he reports his finger hurts, he did not seek medical attention.

Manufacturer Narrative

Device evaluation: result - a review of the device history record was completed for the reported lot # 6137620.All inspections and challenges were performed per the applicable operations qc specifications.This lot was packaged 10jul2016 to 12jul2016.The customer returned (10) 3/10cc, 8mm, 31g syringes in a sealed poly bag from lot # 6137620.All returned syringes were tested to determine the shield removal forces (specs: shield removal force for 3/10cc after sterilization: 0.85-5.95 lbs.).All removal forces fall within specifications.Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure.An absolute root cause for this incident was not determined.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE 0.3ML 31GX5/16"
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6341070
• MDR Text Key: 68050904
• Report Number: 1920898-2017-00019
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

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: 328440
• Device Lot Number: 6137620
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other