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

Catalog Number 381434

Device Problems Retraction Problem (1536); Appropriate Term/Code Not Available (3191)

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

Event Date 07/25/2018

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 had needle retraction failure.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other.D.8.Device single use?: no.H.3.Device returned to manufacture: no.H.6.Investigation summary: although units were not returned, a photo was provided for visual evaluation of this incident.Photo revealed the top web of a blister pack from a 20ga bd insyte autoguard iv catheter, lot 8107748 and ref.381434.Dhr:all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.In process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications.No quality notification were initiated during the build of this lot.Investigation conclusion: observations of the photo provided for the incident did not reveal any actual iv catheter product; therefore the alleged failure of needle retraction failure, as stated in the pir, could not be identified or confirmed.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 had needle retraction failure.There was no report of exposure, serious injury or medical intervention.

• 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: 7782592
• MDR Text Key: 117269459
• Report Number: 1710034-2018-00540
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814344
• UDI-Public: 30382903814344
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 381434
• Device Lot Number: 8107748
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other