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

Catalog Number 306595

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: no samples or photos were provided for investigation.However, a probable root cause of the barrel flange damaged can be induced during the manufacturing process at the plunger rod assembly machine when the infeed scroller has a jam.Based on the investigation carried out and with no sample for analysis, the symptom reported by the customer can¿t be confirmed.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor the associated assembly batches.Investigation conclusion: this is the 3rd complaint for lot # 9308012 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Based on the investigation carried out and with no sample for analysis the symptom reported by the customer can¿t be confirmed.This lot was produced for 1.38mm units this is a cpm of 2.1.We will continue monitoring this product and lot.Root cause description: a probable root cause of the barrel flange damaged can be induced during the manufacturing process at the plunger rod assembly machine when the infeed scroller has a jam.Based on the investigation carried out and with no sample for analysis, the symptom reported by the customer can¿t be confirmed.Rationale: capa not required at this time.

Event Description

It was reported that the bd posiflush¿ normal saline syringe plunger was found broken before use while closing the infusion.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2020, the patient was admitted to the hospital due to the "confirmed gastric cancer in the past three months".The needle handle of flush was found to be broken when the intravenous infusion was closed today, and it was immediately replaced without adverse effects on the patient.".

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10237809
• MDR Text Key: 199141858
• Report Number: 1911916-2020-00609
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 306595
• Device Lot Number: 9308012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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