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

Catalog Number 306564

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

Patient Problem Convulsion/Seizure (4406)

Event Date 07/15/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter email address: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the patient experienced seizures and cyanosis after infusion using the bd posiflush¿ normal saline syringe.This event occurred 3 times.The following information was provided by the initial reporter: "in the emergency service, 3 patients were identified, who presented events such as seizures and cyanotic symptoms, after the infusion was performed using saline from the 5ml posiflush syringe.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12aug2022.It was reported patients were having reactions after using saline from the 5ml posiflush syringe.To aid in the investigation, three samples and two photos were provided for evaluation by our quality team.Two samples are in sealed packaging blisters.One sample came with no packaging blister with 3ml of solution.A visual inspection was performed and no defects or imperfections were observed.The samples were sent to a laboratory for analysis.The results showed there were no defects with the saline solution.One photo shows what appears to be an incident report in a foreign language.The other photo shows a syringe out of the packaging flow wrap.The syringe has the tip cap, solution and the stopper at the 3ml mark.No other information could be obtained from the photos.A device history record review was completed for provided material number 306594, lot number 1229817.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned 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.H3 other text : see h.10.

Event Description

It was reported that the patient experienced seizures and cyanosis after infusion using the bd posiflush¿ normal saline syringe.This event occurred 3 times.The following information was provided by the initial reporter: "in the emergency service, 3 patients were identified, who presented events such as seizures and cyanotic symptoms, after the infusion was performed using saline from the 5ml posiflush syringe.".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15221938
• MDR Text Key: 297858986
• Report Number: 1911916-2022-00425
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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 Catalogue Number: 306564
• Device Lot Number: 1229817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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): Required Intervention