MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE S2 5ML 22GA 1-1/4IN

Catalog Number 301942

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported during use of the bd¿ syringe s2 5ml 22ga 1-1/4in during taking blood, the blood leakage from plunger tip.The patient was born 22 days old and had blood squirted from the tip of the plunger rod and exposed to the nurse's body.The following information was provided by the initial reporter: translated from (b)(6) during taking blood, the blood leakage from plunger tip.The patient was born 22 days old and had blood squirted from the tip of the plunger rod and exposed to the nurse's body.

Manufacturer Narrative

Investigation: bd has reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.No picture or sample available for evaluation.Since the failure could not be confirmed a root cause could not be determined.

Event Description

It was reported during use of the bd¿ syringe s2 5ml 22ga 1-1/4in during taking blood, the blood leakage from plunger tip.The patient was born 22 days old and had blood squirted from the tip of the plunger rod and exposed to the nurse's body.The following information was provided by the initial reporter: translated from chinese during taking blood, the blood leakage from plunger tip.The patient was born 22 days old and had blood squirted from the tip of the plunger rod and exposed to the nurse's body.

• Brand Name: BD SYRINGE S2 5ML 22GA 1-1/4IN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8473525
• MDR Text Key: 141772191
• Report Number: 3002682307-2019-00220
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 301942
• Device Lot Number: 1803170
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other