MAUDE Adverse Event Report: COVIDIEN 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON

Model Number 8881512258

Device Problems Fitting Problem (2183); Failure to Infuse (2340)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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

Customer reports: the plunger on some of the syringes are not moving.

Event Description

The customer reported that the pistons are too loose or too tight.

Manufacturer Narrative

Added h6 health effect - clinical code corrected b5 describe event or problem
corrected h6 medical device problem code
.

• Brand Name: 12ML LUER LOCK TIP PHARM TRAY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11727840
• MDR Text Key: 249676668
• Report Number: 9612030-2021-02876
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010970
• UDI-Public: 10884521010970
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881512258
• Device Catalogue Number: 8881512258
• Device Lot Number: 2030104764
• Date Manufacturer Received: 04/22/2021
• Patient Sequence Number: 1