MAUDE Adverse Event Report: SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA; ANESTHESIA SYRINGE

Catalog Number 301942

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

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.(b)(4).

Event Description

It was reported that a syringe s2 5 ml 22 ga 1-1/4 in bd china leaked.The following information was provided by the initial reporter: "on (b)(6) 2020,the side of the syringe leaked when the nurse injected the patient with progesterone injection after using a disposable syringe of 5 ml".

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 1903280 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.As samples were unavailable for return, our quality team obtained twenty retained samples of the same lot number from the manufacturing facility for further evaluation.Through examination of the retained samples, no defects could be observed.Based on the investigation results, an exact cause could not be determined for this incident.

Event Description

It was reported that a syringe s2 5ml 22ga 1-1/4in bd china leaked.The following information was provided by the initial reporter: "on 2020-07-20,the side of the syringe leaked when the nurse injected the patient with progesterone injection after using a disposable syringe of 5ml".

• Brand Name: SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA
• Type of Device: ANESTHESIA SYRINGE
• MDR Report Key: 10525621
• MDR Text Key: 208560196
• Report Number: 3002682307-2020-00277
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 301942
• Device Lot Number: 1903280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other