MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 1ML LS SP120; PISTON SYRINGE

Catalog Number 303172

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that solution leaked past the syringe 1ml ls sp120 plunger stopper during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "according to the customer's report, the solution leaked from below the plunger.".

Manufacturer Narrative

H6: investigation summary : one sample and photos received for investigation, upon visual inspection of the sample no defects can be observed.Barrel does not present any damage that could have deformed the shape.The stopper is correctly assembled, when the syringe is disassembled the plunger does not show any defect.Upon visual inspection of the pictures provided by customer no leakage can be observed and no defect in the syringe can be noticed.Further testing was conducted, no sign of leakage occurred.A device history review was performed for reported lot 2009067, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that solution leaked past the syringe 1ml ls sp120 plunger stopper during use.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, the solution leaked from below the plunger.".

• Brand Name: SYRINGE 1ML LS SP120
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12416609
• MDR Text Key: 270569437
• Report Number: 3003152976-2021-00544
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: 2009067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1