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

Catalog Number 306595

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

Patient Problems Anaphylactic Shock (1703); Nausea (1970); Vomiting (2144)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Investigation summary: it was reported there were adverse reactions after using the same batch of products.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, one photo that appears to be a letter in a foreign language was provided for evaluation by our quality team.A device history record review was completed for provided material number: 306595, lot number: 2081742.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 no sample analysis the symptom reported by the customer could not be confirmed and 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 patients experienced anaphylactic shock after the bd posiflush¿ normal saline syringes were used to flush the tubing.Additionally, other patients suffered adverse gastrointestinal reactions after the syringes were used on them, as well as nausea and vomiting.No further information was provided.There were a total of 480 occurrences reported for these adverse events.The following information was provided by the initial reporter, translated from chinese: "patients with picc tubes occurred symptoms of anaphylactic shock after using the complaint product to flush the tubes, which improved after emergency rescue.Patients with picc & port had gastrointestinal adverse reactions after using the same batch of complaint products, complaining of odor, nausea and vomiting.".

• 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: 15671547
• MDR Text Key: 302398557
• Report Number: 1911916-2022-00588
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065950
• UDI-Public: (01)00382903065950
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2022

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: 306595
• Device Lot Number: 2081742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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): Other