MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD LUER-LOK TIP SYRINGE; PISTON SYRINGE

Model Number 302832

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: it was reported there is excessive lubricant on the plunger in the syringe body.To aid in the investigation, one sample with no packaging blister in a plastic bag and two photos were received for evaluation by our quality team.A visual inspection was performed on the sample, first with a 10x magnifier lens, and then with a 30x microscope.No defects or imperfections were observed.In the two photos provided, one photo shows a rubber stopper assembled to the plunger out of the syringe barrel.The other photo shows a syringe barrel that has some lubricant at the bottom.This is normal and occurs after pressing the rubber stopper at the bottom of the syringe barrel.The lubricant is medical grade and added to the product to make the movement of the plunger rod-rubber stopper smooth.As the lot provided is 'unknown,' a device history record review could not be completed.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.

Event Description

It was reported when using the bd luer-lok¿ tip syringe there was the following information was provided by the initial reporter.The customer stated: there was "excessive lubricant on the plunger in the syringe body.".

• Brand Name: BD LUER-LOK TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12557250
• MDR Text Key: 274559524
• Report Number: 1911916-2021-01045
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028321
• UDI-Public: 30382903028321
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K980987
• 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: 09/14/2021

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 Model Number: 302832
• Device Catalogue Number: 302832
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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