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

Model Number 21-2767

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

A report was received that, following an infusion, a clinician was removing the device from use with a pt when the clinician pulled back on the safety arm to retract the needle into the safety position.The safety arm was pulled past the safety position, leaving the needle exposed.No needlestick took place.There was no pt or clinician injury.

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.Explanation of method code "other": a sample device was returned and is currently under investigation.

• Brand Name: GRIPPER PLUS NEEDLE
• Type of Device: FPA - SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3940771
• MDR Text Key: 4599926
• Report Number: 2183502-2014-00245
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: 21-2767
• Device Catalogue Number: 21-2767-24
• Device Lot Number: 33X1083
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2014
• Distributor Facility Aware Date: 03/24/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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