MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. HENRY SCHEIN; SINGLE USE SYRINGE

Model Number 900-4476

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that a physician was performing prolotherapy procedure on a 25 year old male patient in an outpatient setting to undergo injection of dextrose 50% into the buttock area just about the greater trochanteric on the left side.Reportedly, when the syringe was pulled out, the needle did not resurface and became fully dislodged and into the patient's buttocks which was realized by the physician upon pulling away the syringe.The patient was admitted to the hospital that evening, stayed overnight and underwent surgery while under general anesthesia the following day.The same day as the surgery the patient was released from the hospital without complications or restrictions.

Manufacturer Narrative

Following an analysis, the syringe was ruled out as the cause for this complaint and a separate investigation was conducted on the needle (see associated mdr #9615588-2023-00001).The syringe involved in this incident has been requested back for an investigation.At this time, the syringe has not been returned and requested photos of it have not been provided.Per 21 cfr 803.16, submission of this report is in no way an admission that the device at issue, the manufacturer or its employees, caused or contributed to this reportable event.The manufacturer explicitly denies such an admission.

• Brand Name: HENRY SCHEIN
• Type of Device: SINGLE USE SYRINGE
• Manufacturer (Section D): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758 5th binhai road; binhai industrial park; longwan district, wenzhou, zhejiang prov 32502 5; CH 325025
• Manufacturer Contact: li suhua ; no. 758 5th binhai road; binhai industrial park; longwan district, wenzhou, zhejiang prov 32502-5 ; CH 325025
• MDR Report Key: 16823549
• MDR Text Key: 314275717
• Report Number: 9615588-2023-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900-4476
• Device Lot Number: 20211010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 25 YR
• Patient Sex: Male