MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG DELTEC® GRIPPER PLUS® SAFETY NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-2767-24

Device Problems Partial Blockage (1065); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

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.

Event Description

It was reported that a deltec® gripper plus® safety needle was blocked from accessing the huber needle safety and placed the nurse at risk of a needlestick.It was observed that the safety component seemed to be soldered.The issue was observed during needle removal at the end of a chemotherapy perfusion for 60 to 90 minutes.No patient or clinician injury was reported.See mfr: 3012307300-2017-00911 and 3012307300-2017-00912.

• Brand Name: DELTEC® GRIPPER PLUS® SAFETY NEEDLES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6498147
• MDR Text Key: 72944968
• Report Number: 3012307300-2017-00913
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025600
• UDI-Public: 10610586025600
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 21-2767-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: No
• 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