MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 5ML SALINE FILL CHINA SP; SALINE FLUSH SYRINGE

Catalog Number 306594

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2020

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 306594 and lot number 0058927.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.Based on the investigation results, an exact cause for this incident could not be identified.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: no sample was received.No photo was provided.Sample analysis could not be performed, and the symptom reported by the customer could not be confirmed.Based on the investigation carried out 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.This lot was produced for (b)(4) units; therefore the cpm is 2.1.

Event Description

It was reported that the syringe 5ml saline fill china sp experienced no label or missing label information the following information was provided by the initial reporter: when the patient was preparing to seal the tube after the infusion, when the outer packaging was opened and used, it was found that there was no label on the bd.Effects on children: none.Take measures: stop using and replace with a new bd.

• Brand Name: SYRINGE 5ML SALINE FILL CHINA SP
• 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: 10796512
• MDR Text Key: 215346982
• Report Number: 1911916-2020-01014
• 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: 11/04/2020

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: 02/28/2023
• Device Catalogue Number: 306594
• Device Lot Number: 0058927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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