MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD RELION INSULIN SYRINGE 1.0ML 30G X 8MM

Catalog Number 311687

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

The medical device expiration date is unknown as the lot number is unknown.The device manufacture date is unknown as the lot number is unknown.

Event Description

It was reported that the needle of the suspect device separated from the hub and remained in the injection site.The customer had x-rays and surgical removal on (b)(6) 2016.

Manufacturer Narrative

Results- a sample is not available for investigation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion- bd was not able to duplicate or confirm the customer¿s indicated failure.Without a sample, an absolute root cause for this incident cannot be determined.

Manufacturer Narrative

Device evaluation: result - the customer returned (2) loose 1cc, 8mm syringes.Customer states that the needle separated from the hub and stayed in the site.Both returned syringes were examined and one sample exhibited a broken cannula.Microscopic examination of the returned sample revealed characteristics such as residual bends on the broken hub end, cracked adhesive and tubing ovality (deformation from the normally circular cross section).When viewed together, these are all indicators of bending/re-straightening mode of failure.Removal of some of the adhesive made this observation more apparent.The shield was also examined for any possible scrapes or cuts related by cannula recapping or improper shielding, however nothing was observed.Conclusion - bd was able to duplicate or confirm the customer¿s indicated failure of needle break off.From the investigation conducted, the root cause appears to be re-use.

• Brand Name: BD RELION INSULIN SYRINGE 1.0ML 30G X 8MM
• 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: 5503892
• MDR Text Key: 40421640
• Report Number: 1920898-2016-00007
• 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,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 311687
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention