MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK ARROW ARTERIAL RETAINER, SELECT PADS 50 BOX; DRESSING, WOUND, DRUG

Model Number N/A

Device Problems Shipping Damage or Problem (1570); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of an open seal was confirmed and the cause appeared to be manufacturing related.One unit pouch for statlock stabilization device was returned for investigation.The product code and lot number on the packaging was art0423 and juctf523, respectively.The pouch contained 2 foam strips.The statlock stabilization device was missing from the pouch.The end of the pouch, opposite from the chevron seal, was open.No evidence of a seal was observed at the open end of the packaging.The manufacturing facility was notified of this complaint.A lot history review (lhr) of juctf523 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported a shipment of arterial statlocks was received with "missing and/or opened" products from the packaging.This file represents the second device received for evaluation.

• Brand Name: STATLOCK ARROW ARTERIAL RETAINER, SELECT PADS 50 BOX
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 8341462
• MDR Text Key: 136750391
• Report Number: 3006260740-2019-00274
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741081392
• UDI-Public: (01)00801741081392
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ART0423
• Device Lot Number: JUCTF523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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