MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 3/10 ML, 31 G X 6 MM BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

Catalog Number 324909

Device Problems Bent (1059); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

Results: two used, loose samples were returned for evaluation.A visual inspection revealed that one of the syringes' needles had penetrated its safety shield.The remaining syringe was tested for point geometry, lube, and cannula outer diameter.The point exhibited proper geometry, the outer diameter was measured as 0.0103¿ (specs: outer diameter for 31g: 0.0100¿-0.0105¿), and sufficient lube was observed.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: at this time, although a visual inspection confirmed that the needle of one of the returned syringes had penetrated its safety shield, an absolute root cause for this incident cannot be determined.The sample has been forwarded to the manufacturing site in (b)(4) for a secondary evaluation.Upon completion of the secondary investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a consumer stuck his finger with a 3/10 ml, 31 g x 6 mm bd insulin syringe with bd ultra-fine¿ needle because the needle was bent and penetrating through its safety cap.There was no report of medical intervention.

Manufacturer Narrative

Results: a secondary investigation was conducted by the manufacturing site in (b)(4).Two used, loose samples were returned for evaluation.A visual inspection revealed that one of the syringes' needles had penetrated its safety shield.Conclusion: our quality engineer notes that this type of defect is seen during assembly, specifically on the lodose (0.3 cc and 0.5 cc) lines.As the parts are assembled linearly, occasionally a cannula may be slightly bent and the force of shielding the hub/needle assembly is sufficient to push the cannula through the shield itself.A capa is not required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: 3/10 ML, 31 G X 6 MM BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• 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: 6476617
• MDR Text Key: 72542654
• Report Number: 1920898-2017-00044
• 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: 05/11/2017

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: 324909
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other