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

Catalog Number 381023

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone #: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that there was leakage at the connector with a bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: when connecting with the ex-tube, blood leaked from the connection.

Manufacturer Narrative

H.6.Investigation summary: bd received a used 22 gauge insyte autoguard blood control unit from an unknown lot number as well as 5 photos of the unit for evaluation.A review of the device history record could not be performed to check for any production issues as the lot was unknown.Our quality engineer visually inspected the returned unit and observed damage to the inner rim of the luer adapter.Next, a water/air leak test was performed for the returned unit and air bubbles were observed coming from the connection site between the catheter and extension tubing.The provided photos also showed the same findings as the returned unit.Based off the visual inspection and testing the engineer was able to verify the reported defect.It was determined that the observed damage was caused by the manufacturing equipment.When the equipment is lowered inside of the adapter it can inadvertently damage it due to an incorrect alignment.Alignment checks are performed during set up.The manufacturing facility has been notified of this incident and the findings.A training was issued for all associates involved to raise awareness of this issue.

Event Description

It was reported that there was leakage at the connector with a bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter, translated from japanese to english: when connecting with the ex-tube, blood leaked from the connection.

• 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: 8654358
• MDR Text Key: 146903368
• Report Number: 1710034-2019-00558
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

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 Catalogue Number: 381023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other