MAUDE Adverse Event Report: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD NIPRO 10CC LL SYRINGE WITHOUT NEEDLE

Model Number JD+10L-WEI

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2020

Event Type  Injury  

Event Description

Staff removed the tego (day to change them) & attached an empty / no needle 10cc syringe to withdraw what was presently in the venous lumen.Staff obtained approx.5 cc solution and immediately went to put the new tego on to the venous lumen.At that time the staff noticed there was something inside the lumen that was preventing from attaching the new tego.Staff attempted for 20 min, to get this plastic piece out of the venous lumen.Treatment lines could not be attached to the venous lumen to start the treatment.Patient's physician was notified.The physician went to the clinic to see the situation and attempt to remove the plastic that was in the venous lumen.He was unsuccessful.Doctor called the vascular physician to tell him about the situation.The vascular physician was able to get the plastic piece out of the venous lumen.According to the staff, the patient was able to complete their scheduled treatment.Incident occurred during catheter preparation for treatment, before treatment started.

• Brand Name: NIPRO 10CC LL SYRINGE WITHOUT NEEDLE
• Type of Device: SYRINGE
• Manufacturer (Section D): SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD; 20 xingshan road; address2 hight tech industrial; weihai 267-2 019; CH 267-2019
• MDR Report Key: 10632314
• MDR Text Key: 215102090
• Report Number: 1056186-2020-00009
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00383790001007
• UDI-Public: 00383790001007
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JD+10L-WEI
• Device Catalogue Number: JD+10L-WEI
• Device Lot Number: 20200108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2020
• Distributor Facility Aware Date: 09/09/2020
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention