MAUDE Adverse Event Report: SMITHS MEDICAL DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-3256-24

Device Problem Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that the needle popped out of the safety and a needlestick occurred.Additional information regarding the event and outcome was requested.

Manufacturer Narrative

The reported ndl, gripper micro, 20g x 0.75" was returned for investigation along with an image and a video.The returned device was received on a container without its original packaging.Visual inspection was performed and the needle of the received sample was moved into the opening of the base and re-assembly to re-activate the safety mechanism.The needle was measured using a calibrated caliper and the click from the safety mechanism could be heard.There was no movement of the needle, and there was no part of the needle showing after it had been secured in place.The needle was measured and it was found that the needle was within specification.The picture and video resulted on the picture showing that the needle is out of the out of the safety mechanism, on the video it was detected that the needle came out of the safety mechanism after the click from the safety mechanism was heard and a small pull is applied to the needle.The instructions for use or ifu state that "failure to use safety arm correctly (lift safety arm straight back to the lock position until it clicks) when removing needle from portal site could result in the needle tip re-emerging from the base, resulting in accidental needle stick with a contaminated needle.No root cause has been determined since the complaint was not confirmed.(b)(4).

• Brand Name: DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL; 1265 grey fox rd.; st paul MN 55112
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5854740
• MDR Text Key: 51410183
• Report Number: 2183502-2016-01686
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-3256-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other