MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 1 CC 31 G X 8 MM; INSULIN SYRINGE AND NEEDLE

Catalog Number 328289

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/02/2016

Event Type  Injury  

Manufacturer Narrative

This device does not have an expiration date.It is unknown if a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the suspect device broke off in the injection site during a humalog injection.He went to urgent care on (b)(6) 2016 and they tried to remove the needle surgically but could not locate it.The customer was advised to go to the hospital where he had an x-ray but the needle was not located.The customer called his doctor, who suggested further follow up scheduled for (b)(6) 2016.At the time of report, the customer had not notified bd of additional follow up.Denies reuse of the device.

Manufacturer Narrative

Result - a sample was not returned for evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 4349690.Conclusions - no samples (including photos) were returned therefore the complaint could not be confirmed and an absolute root cause for this incident cannot be determined.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 1 CC 31 G X 8 MM
• 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: 5606452
• MDR Text Key: 43586196
• Report Number: 1920898-2016-00010
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328289
• Device Lot Number: 4349690
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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): Required Intervention