MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA; PISTON SYRINGE

Catalog Number 301948

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the syringe s2 20ml 18ga 1-1/2in bd (b)(6) leaked blood during use, and those exposed received medical intervention as a result.The following information was provided by the initial reporter, translated from (b)(6) to english: the head nurse complained to the equipment department, the dealer contacted their company, material number (b)(4), batch number: 1904134, during the dialysis reinfusion process of the syringe, the syringe leaked, the syringe pump gave frequent alarms, and the leakage of blood caused the risk of doctor-patient cross-infection.The department nurses responded strongly and refused to use the product, and the remaining syringes in the department have been removed."people who were injured or exposed to blood/body fluids received medical intervention because of the incident".

Event Description

It was reported that the syringe s2 20ml 18ga 1-1/2in bd china leaked blood during use, and those exposed received medical intervention as a result.The following information was provided by the initial reporter, translated from chinese to english: the head nurse complained to the equipment department, the dealer contacted their company, material number 301948 20ml, batch number: 1904134, during the dialysis reinfusion process of the syringe, the syringe leaked, the syringe pump gave frequent alarms, and the leakage of blood caused the risk of doctor-patient cross-infection.The department nurses responded strongly and refused to use the product, and the remaining syringes in the department have been removed."people who were injured or exposed to blood/body fluids received medical intervention because of the incident".

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 1904134 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.All inspections performed during the production process were within specification.To aid in the investigation of this issue, the physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, leakage was observed through the plunger rod component.Damage was identified to the plunger rod through magnified inspection.No signs of leakage were identified in the other fifty-three representative samples returned in addition to the affected sample.It has been determined that the leakage resulted from damage to the plunger lip component.This type of damage can result during the handling of the product throughout the manufacturing facility or during the plunger assembly process.

• Brand Name: SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 10880880
• MDR Text Key: 217698704
• Report Number: 3002682307-2020-00355
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 301948
• Device Lot Number: 1904134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention