MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER NON-CORING NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-2938-24

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Extravasation (1842)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Manufacturing/expiration date was unable to be found based on lot number provided by customer.

Event Description

User facility reported that an oncology patient with an implantable venous access system experienced infiltration of cytotoxic chemotherapy drug near the clavicular area (6 cm from access site) approximately 15 minutes after beginning infusion therapy.The extravasation site was imaged via contrast xray and evidence of kinking of the external connection at 5 cm at the clavicular level was found.Medical intervention was required to remove the catheter from the patient.No other patient or device details were provided.

• Brand Name: DELTEC® GRIPPER NON-CORING NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7720089
• MDR Text Key: 115027790
• Report Number: 3012307300-2018-02835
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023217
• UDI-Public: 10610586023217
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K870866
• 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
• Report Date: 07/25/2018

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
• Device Operator: No Information
• Device Catalogue Number: 21-2938-24
• Device Lot Number: 333356
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention