MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 10ML

Catalog Number 309110

Device Problems Leak/Splash (1354); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 an unspecified number of syringe s2 10ml experienced a breach in sterility and leakage.The following information was provided by the initial reporter: leakage at the plunger site during a medication dose.Medication flows on the fingers + loss of sterility, due to air introduced in the syringe.Clinical consequences observed: none.Immediate actions taken: change of syringe.

Event Description

It was reported that an unspecified number of syringe s2 10ml experienced a breach in sterility and leakage.The following information was provided by the initial reporter: leakage at the plunger site during a medication dose.Medication flows on the fingers + loss of sterility, due to air introduced in the syringe.Clinical consequences observed: none.Immediate actions taken: change of syringe.

Manufacturer Narrative

Investigation: bd has been provided a sample for catalog 309110 lot 1902103 to investigate for this record.A leakage through the plunger rod was observed in this provided sample.Bd could determine a damage in the plunger rod by the evaluation of the plunger with magnification.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.As a result, bd was able to verify the reported issue.Dhr showed no indication of the alleged defect.

• Brand Name: SYRINGE S2 10ML
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8593208
• MDR Text Key: 151779510
• Report Number: 3002682307-2019-00292
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 309110
• Device Lot Number: 1902103
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other