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

Model Number 1182000777

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that two 20cc syringes have been defective, where propofol has leaked past the plunger.One was discovered before use in a push syringe, and an another one was noticed during use, in a syringe being used on a syringe pump.The customer further confirmed that there wasn't a delay or issue with the treatment, as a result of the reported issue.

• Brand Name: 20ML SYR LUER LOCK TIP
• 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: 11456839
• MDR Text Key: 238977886
• Report Number: 1915484-2021-01221
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1182000777
• Device Catalogue Number: 1182000777
• Device Lot Number: 028216X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1