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

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Improper Flow or Infusion (2954)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 05/12/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).Device evaluated by mfr: 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 a child patient receiving a dental extraction had nitrous oxide with oxygen pumped to them while a unspecified bd insyte¿ autoguard¿ bc shielded iv catheter was inserted successfully.However, shortly after the injection of propofol during the induction, the patient experienced a "sudden severe pain" in the arm due to accidental intra-arterial placement, and it was completed with sevoflurane instead.The patient then reported a "burning pain" down their arm during stage 2 recovery while attempting to sleep, but no evidence of ischaemic changes were present following the injection."webairs" data was reportedly consulted for other cases of "unintentional arterial injection", in which four cases identified ante-cubital fossa (acf) as the cannulation site, and a fifth case with the anatomical snuff box (asb) in the hand.Arterial cannulation was recognized before injection in three cases of injected propofol, and one case of injected vancomycin.The propofol cases did not exhibit ischaemia, but the vancomycin showed "duskiness" followed by redness after ten minutes, and was treated with a heparin infusion.Temporary harm was also noted in three cases, and two other cases from the database showed pain in the limb after anesthesia, with one experiencing ischemia.The customer reported 3 total occurrences of this event.The following information was provided by the initial reporter: a child presented for a dental extraction and was initially allowed to breathe nitrous oxide with oxygen whilst a venous cannula was inserted.The type of cannula inserted had a new feature named ¿blood control (bc)¿ which is an automatic check valve, designed to stop the flow of blood after the trochar is removed.There were no difficulties noted during the insertion of the cannula but shortly after the injection of propofol during induction there was sudden severe pain in the arm.It was assumed that an intra-arterial injection of propofol had occurred.The induction was completed with sevoflurane and the cannula re-sited.In stage 2 recovery the patient reported a burning pain down the arm when going to sleep.There was no evidence of ischaemic changes following the injection.The first intravenous cannula inserted, which included the check valve, most likely contributed to the incident by preventing the observation of free flowing pulsatile blood from the artery.The webairs data was interrogated and several other cases of unintentional arterial injection were identified in the database.In four cases the ante-cubital fossa (acf) was the site of the cannulation and in a fifth case it was the anatomical snuff box (asb) in the hand.The anatomical snuff box (asb) and the ante-cubital fossa (acf) are both a high risk for inadvertent arterial cannulation.Propofol was injected in three cases, vancomycin in one case and the arterial cannulation was recognised before injection in one case.The three cases with propofol did not exhibit signs of temporary ischaemia but the case of vancomycin showed duskiness for 10 minutes followed by redness which was treated with a heparin infusion.Temporary harm was noted in three cases.Two of the other cases extracted from the database had pain in the limb after anaesthesia and one experienced ischemia.In two of the other cases no harm was apparent at any stage.

Manufacturer Narrative

Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Root cause is undetermined.Dhr could not be performed.Complaint could not be confirmed.

Event Description

It was reported that a child patient receiving a dental extraction had nitrous oxide with oxygen pumped to them while a unspecified bd insyte¿ autoguard¿ bc shielded iv catheter was inserted successfully.However, shortly after the injection of propofol during the induction, the patient experienced a "sudden severe pain" in the arm due to accidental intra-arterial placement, and it was completed with sevoflurane instead.The patient then reported a "burning pain" down their arm during stage 2 recovery while attempting to sleep, but no evidence of ischaemic changes were present following the injection."webairs" data was reportedly consulted for other cases of "unintentional arterial injection", in which four cases identified ante-cubital fossa (acf) as the cannulation site, and a fifth case with the anatomical snuff box (asb) in the hand.Arterial cannulation was recognized before injection in three cases of injected propofol, and one case of injected vancomycin.The propofol cases did not exhibit ischaemia, but the vancomycin showed "duskiness" followed by redness after ten minutes, and was treated with a heparin infusion.Temporary harm was also noted in three cases, and two other cases from the database showed pain in the limb after anesthesia, with one experiencing ischemia.The customer reported 3 total occurrences of this event.The following information was provided by the initial reporter: a child presented for a dental extraction and was initially allowed to breathe nitrous oxide with oxygen whilst a venous cannula was inserted.The type of cannula inserted had a new feature named ¿blood control (bc)¿ which is an automatic check valve, designed to stop the flow of blood after the trochar is removed.There were no difficulties noted during the insertion of the cannula but shortly after the injection of propofol during induction there was sudden severe pain in the arm.It was assumed that an intra-arterial injection of propofol had occurred.The induction was completed with sevoflurane and the cannula re-sited.In stage 2 recovery the patient reported a burning pain down the arm when going to sleep.There was no evidence of ischaemic changes following the injection.The first intravenous cannula inserted, which included the check valve, most likely contributed to the incident by preventing the observation of free flowing pulsatile blood from the artery.The webairs data was interrogated and several other cases of unintentional arterial injection were identified in the database.In four cases the ante-cubital fossa (acf) was the site of the cannulation and in a fifth case it was the anatomical snuff box (asb) in the hand.The anatomical snuff box (asb) and the ante-cubital fossa (acf) are both a high risk for inadvertent arterial cannulation.Propofol was injected in three cases, vancomycin in one case and the arterial cannulation was recognised before injection in one case.The three cases with propofol did not exhibit signs of temporary ischaemia but the case of vancomycin showed duskiness for 10 minutes followed by redness which was treated with a heparin infusion.Temporary harm was noted in three cases.Two of the other cases extracted from the database had pain in the limb after anaesthesia and one experienced ischemia.In two of the other cases no harm was apparent at any stage.

• Brand Name: UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8645993
• MDR Text Key: 148464876
• Report Number: 2243072-2019-01020
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 06/19/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 05/12/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other