MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. GRIPPER PLUS NEEDLE; FPA - SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-2760

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

User facility reported device was removed from use with patient and user was unable to lock needle into protection device.No adverse effects to patient or user reported.

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow up report detailing the results of the evaluation once it is completed.The actual device involved was returned and is currently under evaluation.

• Brand Name: GRIPPER PLUS NEEDLE
• Type of Device: FPA - SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; st. paul MN
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3976173
• MDR Text Key: 20702810
• Report Number: 2183502-2014-00405
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 21-2760
• Device Catalogue Number: 21-2760
• Device Lot Number: 31V863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PORT-A-CATH