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 Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no sample was received.No photos were provided.Therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non- conformances during manufacturing of the product.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.This is the 1st complaint for lot # 8145616 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: can¿t be confirmed.The sample would help to better understand the reported symptom.It may be a defective molded tip cap or barrel, it could also be a not fully assembled tip cap; however, this condition would induce a leakage of solution at any time and the customer is not reporting incorrect fill or drops of solution in the packaging.Rationale: capa not required at this time.

Event Description

It was reported that the bd posiflush¿ normal saline syringe leaked before use while flushing it.The following information was provided by the initial reporter, translated from (b)(6) to english: "the nurse used the flush to give the patient seal tube according to the correct operating procedure, and fluid outflow occurs during activation.This indicates that the tip cap is not tightly connected to the barrel, and the liquid may not be sterile, so it is not used for patients.".

• 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: 9466780
• MDR Text Key: 194204933
• Report Number: 1911916-2019-01307
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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: 12/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 306595
• Device Lot Number: 8145616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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