MAUDE Adverse Event Report: COVIDIEN 20ML SYR LUER LOCK TIP RP; SYRINGE, PISTON

Model Number 8881520657

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

Per customer, the patient was in training to do hemodialysis at home.In the training room, when the patient has connected a blunt fill needle to the syringe to draw normal saline into syringe, there was leaking noticed around the tip.The staff member was asked to see the syringe and an abnormality in the syringe was noticed.Upon looking closer, the syringe tip was noted to be missing from the inside threads.The patient did not use the product.There was no patient harm reported.

• Brand Name: 20ML SYR LUER LOCK TIP RP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11216710
• MDR Text Key: 228435956
• Report Number: 1915484-2021-01202
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521012155
• UDI-Public: 20884521012155
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881520657
• Device Catalogue Number: 8881520657
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1