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

Catalog Number 381023

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

Patient Problem Death (1802)

Event Date 09/07/2020

Event Type  Death  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga 1.00in was indwelled in a patient when they died.The following information was provided by the initial reporter: "bdj was asked by the customer to investigate whether the product was damaged or not.The details will be reported when additional information becomes available.On 16th sept 2020 new information received.(b)(6) the patient used this product was dead.Date of death is not reported.The customer asked us to perform investigation to see if the product is within specification.No other information is received as of today.21st sept, 2020 (b)(6).The sales rep received following information.Date of death: (b)(6) 2020.Sex: male.Age: 70s.Primary disease: gastric cancer.History: after endoscopic submucosal dissection is done, the patient suddenly went into cardiopulmonary arrest.Cardiopulmonary resuscitation was done though the patient was dead.".

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga 1.00in was indwelled in a patient when they died.The following information was provided by the initial reporter: "bdj was asked by the customer to investigate whether the product was damaged or not.The details will be reported when additional information becomes available.16th sept 2020 new information received.(b)(6).The patient used this product was dead.Date of death is not reported.The customer asked us to perform investigation to see if the product is within specification.No other information is received as of today.21st sept, 2020 (b)(6).The sales rep received following information.Date of death: (b)(6) 2020.Sex: male.Age: 70s.Primary disease: gastric cancer.History: after endoscopic submucosal dissection is done, the patient suddenly went into cardiopulmonary arrest.Cardiopulmonary resuscitation was done though the patient was dead.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used catheter adapter assembly and six photos.Since no specific defect was reported, bd performed a thorough inspection of the unit and its components which involved investigating potential defects involving the adapter, catheter, septum, and actuator.Visual inspection of the device and photos were performed.It was observed that the actuator was pushed through the septum and dried media was present around the septum and base indicating that flow successfully occurred.Through microscopic examination of the catheter tubing, no damaged to the catheter tubing was observed.The catheter tip was inspected and determined to be acceptable.The functional test for leakage was conducted and no leakage was observed.Finally, the actuator and septum were inspected and no damage was observed.The returned unit provided for evaluation met and performed per the required manufacturing specifications.Bd was unable to identify any defects.Dhr was performed.No specific defect was identified by the customer and no defect was found during the investigation, therefore no comment can be made on whether process deviations or quality issues that occurred during manufacturing of the aforementioned lots were related to this defec.

• Brand Name: BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10638787
• MDR Text Key: 210162427
• Report Number: 1710034-2020-00646
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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: 10/01/2020
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death