MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE FLUSH SYRINGE

Catalog Number 306595

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 8019590.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.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.Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no sample analysis a probable root cause could not be offered.

Event Description

It was reported that the 10 ml bd posiflush" normal saline syringe experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: after the patient's infusion, when the nurse went to seal the tube for the patient, he opened the outer package of the disposable flush, and found that one side of the flush wing was broken.It was destroyed and replaced with a new one sealed tube for the patient.

• Brand Name: 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH SYRINGE
• 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 ; 8015296192
• MDR Report Key: 11092099
• MDR Text Key: 225133144
• Report Number: 1911916-2020-01148
• 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: 12/15/2020

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: 01/31/2021
• Device Catalogue Number: 306595
• Device Lot Number: 8019590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2018
• 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