MAUDE Adverse Event Report: BD BD INSYTE AUTOGUARD SHIELDED IV CATHETER ; INTRAVASCULAR CATHETER

Catalog Number 381923

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Erythema (1840); Inflammation (1932); Necrosis (1971); Test Result (2695)

Event Date 07/09/2015

Event Type  Injury  

Manufacturer Narrative

Results: two unused samples, one from lot number 4300687 and one from lot number 4240987, were received for eval.A visual/microscopic analysis of both units revealed the bevel area had the proper bevel cut and the secondary bevel was present.Lie distance was within the acceptable range of.001 - 0.023 inches.The needles were not bent or pinched and there was no gripper damage to the needles.A package leak test was performed fro both units and no leaks or opened seals were observed.A review of the device history record for lot number 4300687 revealed no irregularities during the mfr of the reported lot number.A review of the device history record for lot number 4240987 revealed a quality notification for tip quality that could be associated with this incident however the quality notification review for both lot numbers revealed no related reject activity for either lot number.Sterility records (pyrogen testing) for both lot numbers were reviewed and the pyrogen samples passed all testing.Conclusion: an absolute root cause for this incident cannot be confirmed as the returned units did not display any adverse characteristics that would have contributed to the reported incident.

Event Description

It was reported that while using a bd insyte autoguard shielded iv catheter a pt developed redness, a serious abscess measuring 5cm x 2cm at the iv insertion site, and had an elevated crp.The pt's wound was described as "necrotic" and was treated with hydrogel and allevyn.Of note, the reporting facility could not confirm a lot number for this incident but suspects that it was either lot number: 4300687 or 4240987.Below are the expiration dates and device mfr date for each lot number: 4300687: expiration date: 10/31/2017, device mfr date: october 2014; 4240987: expiration date: 09/30/2017, device mfr date: august 2014.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD ; one becton dr. ; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; one becton dr. ; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 5006620
• MDR Text Key: 23300036
• Report Number: 0001710034-2015-00002
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Not Applicable
• Report Date: 08/11/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 381923
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention