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.The customer also returned one opened pouch of product number ab-18040-n from lot number rf2096425.Visual inspection of the returned pouch revealed that the lidstock of the pouch indicates that the product contains a 17 ga needle.Visual inspection of the returned photograph also confirmed that the lidstock of the product indicates that the contents of the pouch include a 17 gauge needle.Dimensional inspection - the needle packaged in the pouch in the correct 18ga needle that is indicated in the bill of materials.The artwork for the lidstock was reviewed as part of this investigation.A device history record review was performed on the pouch with no findings relevant to this complaint.The complaint 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 19605
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4109112
• MDR Text Key: 4836922
• Report Number: 1036844-2014-00352
• 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
• Date Returned to Manufacturer: 08/26/2014
• 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?: Yes
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1