MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. GRIPPER MICRO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-3271

Device Problem Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that the needle of the listed device was appropriately inserted into the implanted port.Upon removal of the safety device, the needle cover did not engage.The needle cover slid off easily.No harm resulted from this event.

Manufacturer Narrative

One used device sample was returned for evaluation.Visual inspection revealed no abnormalities or product faults.The device was returned in the non-retracted position, with no site returned.Functional testing found the sample to operate as intended.When the device tab was pressed, the arm was found to easily pull into the retracted position, locking into place as intended.The reported product issue could not be duplicated during testing.Review of the device history records revealed no non-conformities during manufacturing.As the returned product was confirmed to operate as intended, no evidence was found to suggest the reported event was related to an intrinsic product problem.

• Brand Name: GRIPPER MICRO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5349004
• MDR Text Key: 35206657
• Report Number: 2183502-2016-00028
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 21-3271
• Device Catalogue Number: 21-3271
• Device Lot Number: 34X915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2014
• 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