MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20GA 1.00IN (1.1 X 25 MM); INTRAVASCULAR CATHETER

Model Number 381433

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 2 bd insyte¿ autoguard¿ shielded iv catheter 20ga 1.00in (1.1 x 25 mm) experienced catheter breakage/separation from hub which was noted during use.The following information was provided by the initial reporter: material no.: 381433 , batch no.: 7165923.Complaint 2 of 2.Per phone call: director of pharmacy explained that the catheter sheath broke off 3 separate times and one time it stayed in the patient but was removed without harm or surgery.Samples discarded but a photo may be provided.Verified lot #7165923 for all 3 incidents.Per email: we received a voicemail from dir of pharmacy requesting a call back regarding complaints with the autoguard product - lot 7165923.

Manufacturer Narrative

H.6 investigation summary: bd received one photograph which displayed a 20ga insyte autoguard iv catheter unit which consisted of the catheter/adapter and the needle/hub assemblies.The needle tip is piercing through the tubing wall near the tip and traces of media are present within the catheter tubing including the tip.There were no indications of the reported defect of the catheter sheath broken off.The media observed within the tip of the catheter tubing and the device indicates a venipuncture was attempted and flashback was observed.It is highly unlikely to achieve a venipuncture and a flashback if this defect was pre-existing as flexible catheter tubing is unlikely to penetrate skin when not guided by the cannula.The reported issue was confirmed as the needle through the catheter.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in your report.A device history record review showed no non-conformance's associated with this issue during the production of these batches.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 2 bd insyte¿ autoguard¿ shielded iv catheter 20ga 1.00in (1.1 x 25 mm) experienced catheter breakage/separation from hub which was noted during use.The following information was provided by the initial reporter: material no.: 381433 batch no.: 7165923 complaint 2 of 2 per phone call: director of pharmacy explained that the catheter sheath broke off 3 separate times and one time it stayed in the patient but was removed without harm or surgery.Samples discarded but a photo may be provided.Verified lot #7165923 for all 3 incidents.Per email: we received a voicemail from dir of pharmacy requesting a call back regarding complaints with the autoguard product - lot 7165923.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20GA 1.00IN (1.1 X 25 MM)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9776610
• MDR Text Key: 185294502
• Report Number: 1710034-2020-00134
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814337
• UDI-Public: 30382903814337
• 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: 04/22/2020

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: 05/31/2020
• Device Model Number: 381433
• Device Catalogue Number: 381433
• Device Lot Number: 7165923
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other