MAUDE Adverse Event Report: NAVILYST MEDICAL XCELA/NAVILYST MEDICAL ; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number H965457420

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

As reported, picc had been placed on (b)(6).Upon flushing by nurse on (b)(6), it was noted to have a cracked luer.The picc was removed and replaced.There was no pt injury or complications from this event.The used device will be returned to navilyst medical for evaluation.

Manufacturer Narrative

Although it has been indicated that the used picc will be returned to navilyst medical for evaluation, it has not yet arrived.Upon receipt of the sample/completion of the investigation, a supplemental medwatch will be submitted (b)(4).

Manufacturer Narrative

The device history records of the reported lot were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The navilyst medical (b)(6) 2015 complaint report was reviewed for the xcela pasv picc product family and the failure mode of " hub broken/cracked." no adverse trends were identified.The reported complaint description cannot be confirmed, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Based on the process controls in place to address this failure mode, however, the most probable root cause for the cracked female valve housing is due to an overtightened connection (most likely with the male luer of the needleless connector).

• Brand Name: XCELA/NAVILYST MEDICAL
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): NAVILYST MEDICAL; glens falls NY
• Manufacturer (Section G): NVAILYST MEDICAL; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: michael duerr ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424571
• MDR Report Key: 4379007
• MDR Text Key: 5115942
• Report Number: 1317056-2014-00118
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

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 Expiration Date: 07/31/2016
• Device Catalogue Number: H965457420
• Device Lot Number: 4783738
• Other Device ID Number: XCELA PASV PICC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2014
• 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 Age: 84 YR