MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of ascts0182 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during the access portion of a patient & pulling back on the saline syringe, blood began squirting back at the patient.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak in the infusion set was confirmed and the cause appeared to be supplier related.One 20g x 3/4¿ safestep infusion set with y-site was returned for investigation.Water leaked from the y-site valve.Under relatively low hydraulic pressure, a continuous leak was observed at the y-site.With increased hydraulic pressure, no fluid leaked at the y-site.A microscopic examination of the y-site revealed what appeared to be a malformed blue valve stem.A microscopic examination of the y-site revealed no damage to the exposed surface of the blue valve stem.The y-site was dissected and the blue valve stem was removed, which revealed material missing from the sealing edge of the valve.The damaged section of valve stem was completely enclosed within the valve housing; therefore, damage during use was unlikely.It was determined that the increasing pressure caused the valve to seal and prevent fluid from leaking through the damaged area of the stem.The supplier was notified of the damaged valve stem.

Event Description

It was reported that during the access portion of a patient & pulling back on the saline syringe, blood began squirting back at the patient.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8076074
• MDR Text Key: 127407220
• Report Number: 3006260740-2018-03232
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066214
• UDI-Public: (01)00801741066214
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

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: 05/28/2021
• Device Model Number: N/A
• Device Catalogue Number: LH-0031YN
• Device Lot Number: ASCTS0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1