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

Model Number	8881512258
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device is not available to 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.This complaint was received via medwatch notification mw5100001 and no initial reporter information was provided.Due to no initial reporter information being provided requests for additional information cannot be completed at this time.If additional information or the sample is received at a later date, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported an issue with a monoject 12ml syringe stating that a patient had a double lumen picc placed and received tpa in both ports at 2200 and 2300.Upon removal of the monoject syringe, it was noted that the plastic nipple of the syringe that inserts into the picc line was missing.Upon examining the port, it was noted that the plastic nipple was in the port.The bedside nurse was aware and the picc line was removed.The medical doctor was notified.No further information can be obtained as the initial reporter was not identified.

• Brand Name: 12ML LUER LOCK TIP PHARM TRAY
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11731750
• Report Number: 9612030-2021-02880
• Device Sequence Number: 4092205
• Product Code: FMF
• UDI-Device Identifier: 10884521010970
• UDI-Public: 10884521010970
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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
• Operator of Device: No Information
• Device Model Number: 8881512258
• Device Catalogue Number: 8881512258
• Device Lot Number: 2021010564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1