MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2868-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Protective Measures Problem (3015)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that after patient use of the deltec® gripper plus® safety needle split septum y-site the nurse was unable to retract the needle into the safety mechanism.The incident resulted in chemotherapy drug leaking onto the patient skin which lead to a skin injury.The skin injury was treated with medication.No permanent adverse effect to the patient was reported.Related mfr #: 3012307300-2017-00777.
Additional Manufacturer Narrative
Two used deltec® gripper plus® safety needles were received for investigation.The device history record for the devices was reviewed and no relevant findings were noted.A visual inspection was performed and it was observed that both safety mechanisms had already been activated and the needles were out of the base.On the back of the arm of both samples, discoloration was observed.Functional testing was performed and the safety mechanism was able to be activated with no problems and the needle was not left exposed.A manufacturing review of a similar device was performed and no discrepancies were detected.The complaint was not confirmed.The most probable root cause was determined to be that the damage to the safety arm occurred after the product left the manufacturing facility.

• Brand Name: DELTEC® GRIPPER PLUS® SAFETY NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6425569
• Report Number: 3012307300-2017-00680
• Device Sequence Number: 13588480
• Product Code: FPA
• UDI-Device Identifier: 10610586025723
• UDI-Public: 10610586025723
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 21-2868-24
• Device Lot Number: 36X676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention