MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

Catalog Number 38181214

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Phlebitis (2004)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6). A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a patient developed phlebitis and an abscess during the time that a bd insyte¿ autoguard¿ shielded iv catheter was used. The patient's hospitalization was extended for monitoring because of the incident, however no medical or surgical interventions were provided.

Manufacturer Narrative

Two representative samples in sealed packages were returned for evaluation. A visual/microscopic inspection revealed that there was no foreign matter on any of the units. The bevel area had the proper bevel cut and the secondary bevel was present. The lie distance was within the acceptable range of. 001 - 0. 023 inches. The cannula tip quality on both units rated b - acceptable. No bends holes, kinks splits or wrinkles were found in the catheter tubing. The catheter tip grading for both units graded a 5 (slightly rough or uneven edge to clean sharp edge) - acceptable. A package leak test was performed and revealed no leaks or opened seals. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5203334. The sterilization process was also reviewed and no abnormalities were found. A quality notification revie revealed one qn ((b)(4)) that could be associated with this incident. The qn involved jagged tip, o-rings and flashed tips. The suspect product was scrapped and is not be an issue for this particular incident. Conclusion: an absolute root cause for this incident cannot be determined as no failure was detected.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5661343
• MDR Text Key: 45370556
• Report Number: 9610048-2016-00002
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 38181214
• Device Lot Number: 5203334
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/17/2016 Patient Sequence Number: 1