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

Catalog Number 382523

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/24/2018

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 piece of plastic was covering the bd insyte¿ autoguard¿ bc shielded iv catheter tip.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that a piece of plastic was covering the bd insyte¿ autoguard¿ bc shielded iv catheter tip.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: a total of (b)(4) units were built and packaged on afa line 12 from 30apr18 through 4may18.1 non related tds were in place during the production of the lot: td 2018-27: allow previous usage of pkg documents all challenge, set-up and in process samples were performed per quality control plan and all passed per specifications.No quality notifications were initiated during production.Received a catheter-adapter assembly, a fully retracted needle-barrel assembly and a piece of top web (packaging) from lot number 8117795.The catheter tubing did not reveal any physical-mechanical damage.The catheter tip was acceptable per specifications and no damage was observed.The unit was rated as 4.No foreign matter could be found on any of the areas of the unit received the water-leak test was performed and no leakage was observed.Conclusion(s): the units received for evaluation did not revealed any manufacturing related damage that would contribute to the failure experienced by the customer.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: 7974315
• MDR Text Key: 124093047
• Report Number: 1710034-2018-00740
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• 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: 11/15/2018

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: 03/31/2021
• Device Catalogue Number: 382523
• Device Lot Number: 8117795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other