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

Catalog Number	21-3368-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.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 or Problem Description
It was reported a deltec® gripper plus® power p.A.C.Safety huber needle was leaking.Patient informed the rn that he felt wetness around his port site.On inspection, the nurse noticed there was a leak at the junction point of the medical needle and the plastic line.Port needle was removed, and patient re-accessed.Remnants of blood were visible at the point of leakage.The patient was exposed to chemotherapy on his skin.The skin was washed as per protocol and the patient was going to follow-up with his physician.No permanent injury was reported.

• Brand Name: DELTEC® GRIPPER PLUS® POWER P.A.C. SAFETY HUBER NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6541776
• Report Number: 3012307300-2017-00972
• Device Sequence Number: 97749
• Product Code: FPA
• UDI-Device Identifier: 10610586033018
• UDI-Public: 10610586033018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

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: 12/20/2021
• Device Catalogue Number: 21-3368-24
• Device Lot Number: 36X1521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY
• Outcome Attributed to Adverse Event: Other