MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 18 G X 1 1/2 IN. BD¿ BLUNT FILL NEEDLE; HYPODERMIC NEEDLE

Catalog Number 305180

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: 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 - without a sample, an absolute root cause for this incident cannot be determined.

Event Description

It was reported that the clinician was drawing from a vial using the suspect device.She had trouble penetrating the vial and the device bounced back, sticking her thumb through her gloved hand.

• Brand Name: 18 G X 1 1/2 IN. BD¿ BLUNT FILL NEEDLE
• Type of Device: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6034448
• MDR Text Key: 57715308
• Report Number: 1911916-2016-00016
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305180
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other