MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381311
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that during use with bd insyte-n¿ autoguard¿ shielded iv catheter death of an infant occurred after antibiotic injection, there was no report of any malfunction of the device.1 of 2 "potentially used" insyte¿ catheter reports.The following information was provided by the initial reporter, translated from french to english: death of an infant a few minutes after venous injection of antibiotics ("amoxicillin" and gentamicin).No explanation to date.Statement concerning 3 models of venous catheter potentially in use.This is associated with another statement concerning the syringe pump, syringe, tubing and non-return valve used in parallel.Current patient status : death.Actions taken in the care facility to manage the patient: judicial investigation, autopsy.
Additional Manufacturer Narrative
The customer stated that our products were ¿potentially in use¿ when this event occurred.Out of an abundance of caution, we will submit mdrs to cover for the products that were potentially involved.We do not suspect that our product caused or contributed to the death 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.
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h10.
Event or Problem Description
It was reported that during use with bd insyte-n¿ autoguard¿ shielded iv catheter death of an infant occurred after antibiotic injection, there was no report of any malfunction of the device.1 of 2 "potentially used" insyte¿ catheter reports.The following information was provided by the initial reporter, translated from french to english: death of an infant a few minutes after venous injection of antibiotics (amoxiciline and gentamicin).No explanation to date.Statement concerning 3 models of venous catheter potentially in use.This is associated with another statement concerning the syringe pump, syringe, tubing and non-return valve used in parallel.Current patient status : death actions taken in the care facility to manage the patient: judicial investigation, autopsy.

• Brand Name: BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17239826
• Report Number: 8041187-2023-00311
• Device Sequence Number: 20148543
• Product Code: FOZ
• UDI-Device Identifier: 00382903813117
• UDI-Public: (01)00382903813117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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?: No
• Operator of Device: Other
• Device Catalogue Number: 381311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown