MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL; PISTON SYRINGE

Catalog Number 300865

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2104094.Medical device expiration date: 03/31/2026.Device manufacture date: 04/20/2021.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 two syringe 50ml ll had leakage issues.The following information was provided by the initial reporter, translated from (b)(6): "when preparing chemotherapy bags, the fluid leaked to the piston.This event was repeated a second time, on a different day, with a syringe of the same reference.".

Event Description

It was reported two syringe 50ml ll had leakage issues.The following information was provided by the initial reporter, translated from french: "when preparing chemotherapy bags, the fluid leaked to the piston.This event was repeated a second time, on a different day, with a syringe of the same reference.".

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 2104094, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Ten retained samples of lot 2104094 were used for additional evaluation.The product was visually inspected, no defects or damage was noted and the stopper was properly assembled onto the plunger rod.

• Brand Name: SYRINGE 50ML LL
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12339377
• MDR Text Key: 267173072
• Report Number: 3003152976-2021-00480
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1