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 05/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.However, a probable cause for the damaged barrel can be induced by a jam during the manufacturing process.Inspections performed while producing this lot were all good.Based on the investigation carried out and with no sample to analyze the symptom reported by the customer can¿t be confirmed.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.This is the 2nd complaint for lot # 9242395 for this type of defect or symptom.This lot was produced for 1.3824mm units this is a cpm of 1.4.We will continue monitoring the performance of this lot.There was no documentation for this type of defect during the entire production run of this batch.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 barrel was found damaged before using it to flush the catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: "the deep vein catheter was placed in the patient's right upper arm.When the responsible nurse used the 10ml prefilled catheter irrigator to flush the catheter for intravenous infusion for the patient, she found that the wall of the prefilled catheter irrigator was damaged and immediately replaced it.".

• 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: 10229550
• MDR Text Key: 200063174
• Report Number: 1911916-2020-00595
• 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

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 306595
• Device Lot Number: 9242395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2019
• 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