MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of ascvs0001 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was a leak from y site (white).No other information was provided.
Event or Problem Description
It was reported that there was a leak from y site (white).No other information was provided.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a y-site leak was confirmed but the exact cause remains unknown.One 22 ga x 1 in safestep infusion w/site was returned for investigation.The package label was returned with lot: ascvs0001.The safety mechanism was returned fully activated.The proximal luer hub was flushed with water using a 12 ml syringe and a spraying leak was observed from the y-site hub.Microscopic observation of the leak location revealed two longitudinal cracks in the white portion of the y-site hub.The cracks were located at opposite ends from each other.One of the cracks went along the injection gate location.The cracks extend from the lower end to the top end of the cylindrical region on the white hub.Additional surface damage was not observed.Based on the condition of the returned sample, possible contributing factors include over-tightening and attachment to incompatible component.Since the exact cause to the formation of the cracks remains unknown, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of ascvs0001 showed no other similar product complaint(s) from this lot number.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 1 IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10395438
• Report Number: 3006260740-2020-02895
• Device Sequence Number: 19518931
• Product Code: FPA
• UDI-Device Identifier: 00801741066191
• UDI-Public: (01)00801741066191
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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 Expiration Date: 07/28/2021
• Device Model Number: N/A
• Device Catalogue Number: LH-0030YN
• Device Lot Number: ASCVS0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1