MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU PEGASUS YEL 24GA X 0.75IN PRN NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383715

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

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418)

Event Date 08/03/2021

Event Type  Death  

Manufacturer Narrative

Date of birth: patients birthday was not provided, (b)(6) was used based on age of patient.Investigation summary: in response to the event reported a device history review was conducted for the provided lot number.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Review of the assembly/packaging/sterilization record, showed no nonconformities, deviations or rework activities for this lot product.Unfortunately, a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.Possible root cause analysis: according to the complaint information feedback, the patient was treated with gamma globulin due to compromised immunity, loss of consciousness during the infusion, cardiac arrest and the patient died after being transferred to icu; after the accident, the hospital sealed up the gamma globulin, blood transfusion device and infusion device used for treatment the bd pegasus plus indwelling needle was indwelling at (b)(6) used as a therapeutic drug infusion, the bd pegasus plus indwelling needle been removed at (b)(6) 4 pm after rescue failed, and the device was not sealed up and was treated as medical waste.According the case feedback there no any defect or abnormal reported with bd pegasus plus device during the treatment.Per the communication from bd sale rep and hospital, for this kind serious accident all the medical fluids and instruments used in the treatment will report to (b)(6) system by hospital, including our pegasus plus product.Reviewed the assembly/packaging/sterilization record, there no nonconformities, deviations or rework activities for this lot product; reviewed the in process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormal for it.Reviewed the complaint history record, no any record for the defect of death with bd pegasus products.Cannot confirm this case it related with bd pegasus indwelling device.

Event Description

It was reported pegasus yel 24ga x 0.75in prn non-pvc was involved in patient death.The following information was provided by the initial reporter, translated from (b)(6): "the patient was (b)(6) male.On (b)(6) he was admitted to (b)(6) hospital respiratory second division.Due to the low immunity of the patient, the doctor gave gamma globulin treatment.In the process of infusion, the patient was in loss of consciousness and cardiac arrest, then he was transferred to pediatric icu and died after rescue failed.".

• Brand Name: PEGASUS YEL 24GA X 0.75IN PRN NON-PVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12474384
• MDR Text Key: 271472268
• Report Number: 3014704491-2021-00138
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2024
• Device Catalogue Number: 383715
• Device Lot Number: 1110734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 12 YR