MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEEDLES AND SYRINGES; SYRINGE, PISTON

Model Number UNKNOWN NS

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

To date, the initial reporter has not provided the item code.As a result, the udi could not be identified.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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the luer lock syringe tip broke off into extension tubing after ampicillin administration.

• Brand Name: UNKNOWN NEEDLES AND SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12516650
• MDR Text Key: 272905414
• Report Number: 1424643-2021-00617
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2021

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: UNKNOWN NS
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/22/2021
• Type of Device Usage: N
• Patient Sequence Number: 1