MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306594

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

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

Event Type  Death  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used.Investigation summary: it was reported in the process of intravenous injection with gamma globulin, the patient suffered sudden consciousness loss and cardiac arrest.As a sample was unavailable for return, a thorough sample investigation could not be completed.A device history and sterilization record review was completed for provided material number 306594, lot number 1057946.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported result.There was no documentation of any defect during the entire production run of this batch.The sterilization records were reviewed confirming that sterilization was compliant to requirements.To date, there have been no other similar events reported for this lot.A review of the applicable end user risk assessments indicate that the potential risk of the reported event was assessed appropriately in the risk management documentation.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd posiflush¿ syringe was used in conjunction with intravenous gamma globulin injection, but the patient suffered a sudden loss of consciousness, went into cardiac arrest, and passed away after rescue attempts.No further information was provided by the customer.The following information was provided by the initial reporter, translated from (b)(6) to english: "in the process of intravenous injection with gamma globulin, the patient suffered suddenly consciousness loss and cardiac arrest, and patient was dead after rescue".

• Brand Name: BD POSIFLUSH SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12471103
• MDR Text Key: 271430771
• Report Number: 1911916-2021-00986
• Device Sequence Number: 1
• Product Code: NGT
• 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: 09/02/2021

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: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 306594
• Device Lot Number: 1057946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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