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); Separation Failure (2547); 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: 3012307300-2017-00912 and 3012307300-2017-00913.

Manufacturer Narrative

One smiths medical gripper plus® safety needle was received for analysis in a used condition inside a plastic bag.Visual inspection performed at 12'' to 24'' revealing that solvent was attached to the arm safety mechanism which was adhered to the base through the top side of the needle.In order to verify that the safety mechanism was adhered to the base, functional testing was attempted to try to separate the arm to the base.Relevant documents were reviewed and deemed adequate with respect to testing and inspection activities.The following operations were reviewed in order to verify that the operations were properly performed: the bonding operation between the tube and the ay base was reviewed with no discrepancies noted; bonding process reviewed; training records were reviewed with no discrepancies.A review of 32 units were visually inspected to assess for solvent marks at the base with no findings.Five samples were tested by pulling the arm to activate the safety mechanism with no hinge activation findings.Based on the evidence, the complaint was confirmed.The most probable root cause was that the gripper base came in contact with the solvent used in the manufacturing process.

• 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: 6498139
• MDR Text Key: 72945576
• Report Number: 3012307300-2017-00911
• 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,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/17/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/03/2018
• 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