MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported via ms&s, "caller asking for the material contents of the safestep port access needle.She states she is having a reaction to this device product code lh-0032.She states her skin is red and blistering.She states she has used the deltec gripper plus device with 3m sensitive tape and iv3000 without issue.She states her insurance changed and sent the safestep needle used with the same 3m sensitive tape and iv3000 but now having issues.The doctor instructed her to change back to the deltec product but the insurance company will not allow it.Ms&s "explained that the safestep needle itself is stainless steel.The tubing and housing (fluid path) contain pvc rigid and flexible, abs, polycarbonate, silicone, and acrylic adhesive.".

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 9727919
• MDR Text Key: 180177174
• Report Number: 3006260740-2020-00549
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066221
• UDI-Public: (01)00801741066221
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0032
• Was Device Available for Evaluation?: No
• Event Location: Home
• Date Manufacturer Received: 01/29/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other