MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381511

Device Problems Gas/Air Leak (2946); Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the bevel area of the bd insyte-n¿ autoguard¿ shielded iv catheter tip is bubbled.It was also reported that there is difficulty penetrating the skin, no or very little flashback, and veins are blowing.This is leading to more central lines (uvc¿s) being placed due to inability to get piv in place successfully which is higher risk for infection and other complications.The following information was provided by the initial reporter: material no.: 381511 batch no.: 8275532.It was reported that the bevel area of the catheter tip is bubbled.It was also reported that there is difficulty penetrating the skin, no or very little flashback, and veins are blowing.This record is for patient (b)(6) on (b)(6) 2019.

Event Description

It was reported that the bevel area of the bd insyte-n¿ autoguard¿ shielded iv catheter tip is bubbled.It was also reported that there is difficulty penetrating the skin, no or very little flashback, and veins are blowing.This is leading to more central lines (uvc¿s) being placed due to inability to get piv in place successfully which is higher risk for infection and other complications.The following information was provided by the initial reporter: material no.: 381511 batch no.: 8275532 it was reported that the bevel area of the catheter tip is bubbled.It was also reported that there is difficulty penetrating the skin, no or very little flashback, and veins are blowing.This record is for patient (b)(6) on (b)(6) 2019.

Manufacturer Narrative

H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.

• Brand Name: BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8566686
• MDR Text Key: 143675999
• Report Number: 1710034-2019-00473
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815112
• UDI-Public: 30382903815112
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 381511
• Device Lot Number: 8275532
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other