MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 6MM INSULIN SYRINGE

Catalog Number 324907

Device Problem Physical Resistance (2578)

Patient Problems Cellulitis (1768); Inflammation (1932)

Event Date 07/15/2016

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.It is unknown whether the actual suspect device will be returned for evaluation.

Event Description

It was reported that after experiencing difficulties injecting with the suspect device (unexpected resistance while pushing plunger), the patient visited her doctor for inflammation at the injection site.Patient was diagnosed with cellulitis and prescribed on antibiotics; she was then referred to a cardiologist.The cardiologist subsequently referred the patient to a vascular specialist who ordered a doppler study of the site.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The patient sustained a weight gain of 8 pounds when her leg "swelled up like a balloon." it is additionally reported that the patient has been using the product many years; that the cellulitis and leg swelling, for which she required the previously reported vascular doppler studies and antibiotics, are only recent events.She does not reuse these needles, and does rotate her injection site, dosing twice daily.Her doses are 10 units and 30 units of levemir.The cellulitis has resolved and she is now able to inject the medication easily; the patient reports that she had had problems with the plunger before, during and after the onset of the cellulitis.Customer is wondering if recent increase in dose had something to do with the issue.Correction: medical device expiration date: this device does not have an expiration date.Correction: "fda notified?" response changed to "unknown." correction: medical device manufacture date: corrected to 8/17/2015.

Event Description

The patient sustained a weight gain of 8 pounds when her leg "swelled up like a balloon." it is additionally reported that the patient has been using the product many years; that the cellulitis and leg swelling, for which she required the previously reported vascular doppler studies and antibiotics, are only recent events.She does not reuse these needles, and does rotate her injection site, dosing twice daily.Her doses are 10 units and 30 units of levemir.The cellulitis has resolved and she is now able to inject the medication easily; the patient reports that she had had problems with the plunger before, during and after the onset of the cellulitis.Customer is wondering if recent increase in dose had something to do with the issue.

Manufacturer Narrative

Results: customer returned (13) loose 1/2cc, 6mm syringes.All returned syringes were examined and no defects were visible on any of the returned samples.All samples were then tested and all were able to draw and expel properly without any observed defects.A review of the device history record revealed that there were no notifications noted for any related defect during the production of lot# 5229821.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure.Without the suspect device, an absolute root cause for this incident cannot be determined.

• Brand Name: BD ULTRA-FINE¿ 6MM INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• 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: 5841937
• MDR Text Key: 51001731
• Report Number: 1920898-2016-00021
• 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: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Catalogue Number: 324907
• Device Lot Number: 5229821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• 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