MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number 1183500777

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Medwatch mw5093742 was received on 27-aug-2020; however, the form did not include facility information or contact information.As a result, additional information nor sample information could be requested.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 states that the iv teach was using the syringes and noticed a white residue/substance on the inside of the barrel.The tech said one syringe looked like it had a black hair on it also.Possible lots 922459x or 921043x.

• Brand Name: 35ML SYRINGE 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: 10465412
• MDR Text Key: 204730478
• Report Number: 1915484-2020-01187
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010826
• UDI-Public: 10884521010826
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1183500777
• Device Catalogue Number: 1183500777
• Date Manufacturer Received: 08/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1