MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK TIP SYRINGE; PISTON SYRINGE

Model Number 309653

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 309653 and lot number 0118610.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.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.

Event Description

It was reported that the bd luer-lok¿ tip syringe leaked during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: ¿patient's spouse reported that they had to get a new pump this summer as the syringes were leaking and gumming up the pump that they had.Previous pump was approximately 8 years old; however this has happened another 3-4 times since.Patient's spouse has indicated that he believes there may have been something wrong with the syringes.It was not clear how much of the medication may have been missed.¿.

• Brand Name: BD LUER-LOK TIP SYRINGE
• Type of Device: PISTON 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12542090
• MDR Text Key: 273772593
• Report Number: 1911916-2021-01029
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 309653
• Device Catalogue Number: 309653
• Device Lot Number: 0118610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• 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