MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0029

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is inconclusive due to poor sample condition.One photo of a safestep infusion set label with ref: lh-0029 and lot: ascps0035 was returned for evaluation.The complaint of a leak could not be confirmed from the photo sample provided.Based on the description of the reported event, possible contributing factors include sharp instrument damage and tensile damage.A lot history review (lhr) of ascps0035 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that leaking was noted at the hub of the port access needle.Additional information from sales representative on 12/07/2018: the safestep was connected to tubing from a drip set and normal saline ran through the hub of the port.The staff nurse in charge of this patient found that the patient shirt was slightly wet and thus brought this issue to customer contact.They suspected that there was a leak somewhere but they were unable to confirm with visual inspection.However in view of safety and precaution, they informed the patient that a new needle will be inserted to complete the chemotherapy session.A new needle was inserted and the chemotherapy session was completed.The customer contact took the suspected safestep that had been taken out of the patient and tested it with a 10 ml luer lock syringe.She locked the syringe at the safestep hub and injected (pushed) saline slowly through the needle.She observed a small drop of liquid at the connection when all the fluid was pushed through the needle.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7733056
• MDR Text Key: 115648044
• Report Number: 3006260740-2018-01872
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: LH-0029
• Device Catalogue Number: LH-0029
• Device Lot Number: ASCPS0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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