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

Catalog Number 21-3271-24

Device Problem Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

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

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

Manufacturer Narrative

The reported 22g needle gripper micro® was returned for investigation.The device was received without its original packaging.During visual inspection a white discoloration was observed on the arm of the device.Also, damage was found on the back of the safety mechanism located on the needle arm.During functional testing, no audible click was heard when attempting to engage the needle into the safety mechanism.Upon examination, it was found that the safety mechanism of the needle did not function properly due to the damage found on the back of the needle arm.Investigation was unable to determine the root cause of the damage observed on the back of the needle arm.Mfr# clarification: new registration number 3012307300 (b)(4) has been received, however, this initial mdr was filed under the prior registration number 2183502 (b)(4).

• Brand Name: DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET.
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave, calidad no.; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave, calidad no.; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5830019
• MDR Text Key: 50658694
• Report Number: 2183502-2016-01627
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-3271-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2016
• 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