MAUDE Adverse Event Report: ARROW INTL., INC. ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2"); NERVE BLOCK NEEDLE

Catalog Number AB-18040-N

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the contents label indicates 17ga and it should be 18ga.

Manufacturer Narrative

The customer returned one photograph of the shipping papers and the lidstock of the device for investigation.Visual inspection of the returned photograph revealed that the lidstock of the pouch indicates that the contents of the pouch include a 17 gauge needle.Based on the bill of materials of the pouch in agile, and it was confirmed that the pouch should contain an 18 gauge needle.The contents of the lot number provided, rf2096425, indicated that part number k-18040-001 was packaged in this kit which is the correct part; and 18 gauge needle.The lot number contents also confirmed that lot number was packaged with the substitution lidstock, part number b-18040-132a.A review of the artwork for this lidstock in agile confirmed that the lidstock is designed with the incorrect needle info.The primary lidstock artwork was also reviewed as part of this complaint investigation.A review of the primary lidstock revealed that the primary lidstock is designed with the correct info.A device history record review was performed on the pouch with no findings relevant to this complaint.The complaint (incorrect label) is confirmed.The potential root cause is labeling.A nonconformance was initiated to further investigate this complaint issue.

• Brand Name: ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
• Type of Device: NERVE BLOCK NEEDLE
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4109113
• MDR Text Key: 4700565
• Report Number: 1036844-2014-00353
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB-18040-N
• Device Lot Number: RF2096425
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1