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

Catalog Number H965458810

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records (dhr) was performed for the indicated packaging and component lots 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 june 2015 navilyst medical complaint report was reviewed for the bioflo picc family and the failure mode "leakage".No adverse trends were identified.The reported complaint description cannot be confirmed, nor can a definitive root cause for this incident be determined, as no sample was returned for eval.The dhr search revealed no quality related issues or mfg deficiencies at the time of mfr.Mfg process controls for the bioflo picc devices include visual inspection for damage or defects, various dimensional verifications and a tensile test of the molded luer-to-tube based on an aql.A 100% in process visual inspection for molding defects and a guidewire insertion test to verify lumen patency is required.In addition, al catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.(b)(4).

Event Description

As reported by navilyst medical's distributor in (b)(4), a pic placed on (b)(6) 2015 was found to have "a hole and leakage at the distal end of the suture wing".The catheter was removed and will not be returned.The pt condition was reported as "stable".

• Brand Name: BIOFLO/ NAVILYST MEDICAL
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): NAVILYST MEDICAL ; glens falls NY
• Manufacturer (Section G): NAVILYST MEDICAL ; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 4992816
• MDR Text Key: 24776211
• Report Number: 1317056-2015-00151
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: H965458810
• Device Lot Number: 4808503
• Other Device ID Number: BIOFLO PASV PICC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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