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

Catalog Number 306595

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the customer provided one photo for evaluation.It shows two syringes in a plastic bag.Both samples have no tip cap, and the plunger rod-rubber stopper is at 4.5ml of the scale.Since no physical samples displaying the condition reported are available for examination, we were unable to investigate it thoroughly.A potential root cause could not be determined.Analysis of the product involved may provide clarification as to the cause of the reported 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 1st complaint for lot # 9308010 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.This lot was produced for 1.4304mm units this is a cpm of 0.7.We will continue monitoring the performance of this lot.Root cause description: based on the investigation carried out and with no sample to analyze the symptom reported by the customer can¿t be confirmed nor could the symptom be correlate with a root case linked to the manufacturing process.Rationale: capa not required at this time.

Event Description

It was reported that the bd posiflush¿ normal saline syringe plunger couldn't be pushed past the halfway mark.This occurred with 2 different syringes during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "in the process of using the product, the plunger couldn't be pushed on the half way.".

• 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: 10229557
• MDR Text Key: 199137540
• Report Number: 1911916-2020-00594
• 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: 06/18/2020

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: 9308010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/03/2020
• 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