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

Catalog Number 21-2762-24

Device Problem Fluid/Blood Leak (1250)

Patient Problems Edema (1820); Extravasation (1842); Tingling (2171)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating that during a bolus of medication through a smiths medical deltec® gripper plus® safety needle the patient reported tingling and noted edema to the side of the perfusion.The infusion was stopped, doctor notified and extravasation protocol initiated.The patient was subsequently admitted to the hospital overnight for observation and discharged home the following day with no adverse effects.

• Brand Name: DELTEC® GRIPPER PLUS® SAFETY NEEDLES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING; s.a. de c.v.; a d no.4 parque industrial int; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7149806
• MDR Text Key: 95896244
• Report Number: 3012307300-2017-02654
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025556
• UDI-Public: 10610586025556
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/27/2017

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?: No
• Device Operator: Nurse
• Device Expiration Date: 10/04/2022
• Device Catalogue Number: 21-2762-24
• Device Lot Number: 37X1292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Weight: 45