MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE S2 5ML

Catalog Number 309050

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 the plunger had a defect with a bd syringe s2¿ 5ml.The following information was provided by the initial reporter, translated from (b)(6) to english: defect of the plunger, air bubble formation from the bottom of the syringe and leakage of the contents.Problem occurred on 3 syringes of the same batch.

Manufacturer Narrative

Investigation: bd has been provided with 90 reference samples for catalog 309050 lot 1812174 to investigate for this record.Leakage test were carried out accordingly and it was determined that the samples did not present the reported defect.Unfortunately, as a result, bd was unable to verify the reported issue and determine a definitive root cause.Dhr showed no indication of the alleged defect.

Event Description

It was reported that the plunger had a defect with a bd syringe s2¿ 5ml.The following information was provided by the initial reporter, translated from french to english: defect of the plunger, air bubble formation from the bottom of the syringe and leakage of the contents.Problem occurred on 3 syringes of the same batch.

• Brand Name: BD SYRINGE S2 5ML
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8546276
• MDR Text Key: 144451277
• Report Number: 3002682307-2019-00268
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 309050
• Device Lot Number: 1812174
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other