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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9727919
• Report Number: 3006260740-2020-00549
• Device Sequence Number: 16718328
• Product Code: FPA
• UDI-Device Identifier: 00801741066221
• UDI-Public: (01)00801741066221
• Combination Product (Y/N): N
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0032
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/19/2020
• 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: Other