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

Catalog Number 381844

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Phlebitis (2004)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.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 patient experienced an adverse event where the bd insyte¿ autoguard¿ shielded iv catheter had been placed.The following was received by the initial reporter: the patient presents in her upper limbs, where catheter was placed, a point of infection at the catheter insertion site, additionally presenting blushing and redness in the area.It was noted in the right upper limb that the patient presents edema, redness, inflammation in site where the peripheral venous catheter number 18 was placed.Due to the fact that the patient was received in the early hours of the morning, by institutional protocol, the venous access must be exchanged, it was 5 a.M., the appropriate process was performed following the appropriate protocol, where phlebitis is noted, with redness in the fold of the left upper limb, the report is performed once the issue was noted, and later a 20ga catheter was placed in a single puncture in the same left upper limb without conflicting the phlebitis, due to the fact that in the right upper limb there were bandages and surgical wounds.

Event Description

It was reported that patient experienced an adverse event where the bd insyte¿ autoguard¿ shielded iv catheter had been placed.The following was received by the initial reporter: the patient presents in her upper limbs, where catheter was placed, a point of infection at the catheter insertion site, additionally presenting blushing and redness in the area.It was noted in the right upper limb that the patient presents edema, redness, inflammation in site where the peripheral venous catheter number 18 was placed.Due to the fact that the patient was received in the early hours of the morning, by institutional protocol, the venous access must be exchanged, it was 5 a.M., the appropriate process was performed following the appropriate protocol, where phlebitis is noted, with redness in the fold of the left upper limb, the report is performed once the issue was noted, and later a 20ga catheter was placed in a single puncture in the same left upper limb without conflicting the phlebitis, due to the fact that in the right upper limb there were bandages and surgical wounds.

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17558098
• MDR Text Key: 321275752
• Report Number: 2243072-2023-01461
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: (01)00382903818440
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

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: 381844
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other