MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP SAFETY INFUSION SET 20G X 0.75 INCH WITH NEEDLELESS Y-SITE; HYPODERMIC SINGLE LUMEN NEEDLE.

Catalog Number	CPA00010A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reby0612 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby0612) have been reported from the same facility.
Event or Problem Description
It was reported the y-site on the huber (the inner blue septum on the y-site) leaked upon infusion (not accessed prior to).
Additional 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, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed.One 20 ga x 0.75 in safestep infusion set was returned for investigation.Use residue was observed within the sample.The sample was flushed with water using a 12 ml and was found to be patent to infusion.During pressurization, a bead of water was observed to leak at the blue valve at the ¿y¿ site.The ifu states, ¿needleless y-injection site valve may leak slightly at certain pressures resulting in a small bead of fluid on the valve.¿ as a bead of water was observed to leak, the complaint is confirmed.A lot history review (lhr) of reby0612 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby0612) have been reported from the same facility.
Event or Problem Description
It was reported the y-site on the huber (the inner blue septum on the y-site) leaked upon infusion (not accessed prior to).

• Brand Name: SAFESTEP SAFETY INFUSION SET 20G X 0.75 INCH WITH NEEDLELESS Y-SITE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE.
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7487707
• Report Number: 3006260740-2018-00892
• Device Sequence Number: 1677611
• Product Code: FPA
• UDI-Device Identifier: 00801741136658
• UDI-Public: (01)00801741136658
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: CPA00010A
• Device Lot Number: REBY0612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1