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

Catalog Number 381423

Device Problems Backflow (1064); Leak/Splash (1354); Failure to Advance (2524); Material Twisted/Bent (2981)

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

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd insyte¿ autoguard¿ shielded iv catheter made a puncture site larger than the catheter remaining in patient causing a back flow of blood under the tegaderm.Nurses also reported the following, "it was reported the needle was bent and would not advance." "there still has not been any follow up to the issues we are experiencing with the 22g angiocaths we first reported at the end of january.We need some resolution to this asap.Below i have attached the picture of the old autoguard 22g that we did not have any issues with vs.The nw 22g autoguard that is leaking and causing patient safety issues." "random catheters made a puncture site larger than the catheter remaining in patient causing a back flow of blood under the tegaderm." "according to our event reporting system both of the events occurred on (b)(6) 2019.Below is what how the staff members described the incidents.Bd insyte autoguard catheter.Difficulty advancing catheter.Nurse received flash when inserting iv but unable to advance catheter.Product is flimsy and unable to advance into the vein bd insyte autoguard iv catheter lot #8220859.Issue with advancing the catheter.Upon insertion nurse received flash and was visibly in the vein, however catheter was unable to advance into the vein.Catheter is flimsy and bends when attempts to advance are made.".

Manufacturer Narrative

H.6.Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect.No physical samples were received for testing and evaluation; one photo was provided for evaluation of this incident.Photo displayed two package labels which revealed the bd logo, ref no., description, lot number and the expiration date.Visual/microscopic evaluation: based on the review of the submitted photo the defects catheter kinked/bent and needle penetration difficult/painful was not identified or confirmed.The photo was of two package labels.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

Event Description

It was reported that a bd insyte¿ autoguard¿ shielded iv catheter made a puncture site larger than the catheter remaining in patient causing a back flow of blood under the tegaderm.Nurses also reported the following, "it was reported the needle was bent and would not advance."there still has not been any follow up to the issues we are experiencing with the 22g angiocaths we first reported at the end of january.We need some resolution to this asap.Below i have attached the picture of the old autoguard 22g that we did not have any issues with vs.The nw 22g autoguard that is leaking and causing patient safety issues." "random catheters made a puncture site larger than the catheter remaining in patient causing a back flow of blood under the tegaderm." "according to our event reporting system both of the events occurred on (b)(6) 2019.Below is what how the staff members described the incidents.Bd insyte autoguard catheter.Difficulty advancing catheter.Nurse received flash when inserting iv but unable to advance catheter.Product is flimsy and unable to advance into the vein bd insyte autoguard iv catheter lot #8220859.Issue with advancing the catheter.Upon insertion nurse received flash and was visibly in the vein, however catheter was unable to advance into the vein.Catheter is flimsy and bends when attempts to advance are made.".

• Brand Name: BD INSYTE¿ 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: 8405993
• MDR Text Key: 138651173
• Report Number: 1710034-2019-00273
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814238
• UDI-Public: 30382903814238
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 381423
• Device Lot Number: 8220859
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other