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

Catalog Number 382533

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

Patient Problems Extravasation (1842); Pain (1994); Thrombus (2101)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter cannula separated from the hub after removing it from the patient during use, but was not noticed.The patient experienced pain in the arm for "several weeks" after the iv removal, and it was believed that the broken cannula had remained in the vein, requiring surgical intervention to remove it.However, additional information from the customer confirms that "there was no evidence of a catheter in the vein tissue", and the vein had a significant clot present, leading the physician to have believed that the "ridge" felt on the patient's forearm was the catheter, when it was "likely" the clot.The following information was provided by the initial reporter: "patient had a 20g 1 inch insyte iv catheter inserted.The iv became interstitial and the iv was removed.Nurse did not notice that the iv cannula had separated from the hub.The patient continued to have pain in his arm for several weeks and upon consultation with a physician it was identified the cannula was still in the vein.Patient required surgical intervention to removed the cannula." "i have confirmed with our pathology lab that there was no evidence of a catheter in the vein tissue specimen retrieved at the time of surgery.Only one specimen retrieved so nothing identified.The vein was traumatized with a significant clot present which was quite firm, so to the surprise of everyone the ridge felt on the patient¿s forearm was likely that rigid clot.".

Manufacturer Narrative

Investigation summary: there were no samples or photos available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter cannula separated from the hub after removing it from the patient during use, but was not noticed.The patient experienced pain in the arm for "several weeks" after the iv removal, and it was believed that the broken cannula had remained in the vein, requiring surgical intervention to remove it.However, additional information from the customer confirms that "there was no evidence of a catheter in the vein tissue", and the vein had a significant clot present, leading the physician to have believed that the "ridge" felt on the patient's forearm was the catheter, when it was "likely" the clot.The following information was provided by the initial reporter: "patient had a 20g 1 inch insyte iv catheter inserted.The iv became interstitial and the iv was removed.Nurse did not notice that the iv cannula had separated from the hub.The patient continued to have pain in his arm for several weeks and upon consultation with a physician it was identified the cannula was still in the vein.Patient required surgical intervention to removed the cannula." "i have confirmed with our pathology lab that there was no evidence of a catheter in the vein tissue specimen retrieved at the time of surgery.Only one specimen retrieved so nothing identified.The vein was traumatized with a significant clot present which was quite firm, so to the surprise of everyone the ridge felt on the patient¿s forearm was likely that rigid clot.".

• 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: 8857235
• MDR Text Key: 153158081
• Report Number: 1710034-2019-00841
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382533
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention