MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2020
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 asdvf039 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the patient was accessed on (b)(6) 2020 and sent home with port accessed (heparin locked per institution policy).Upon checking port needle a crack was noted on (b)(6) 2020.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of cracked infusion set y-sites was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 20ga x 0.75¿ miniloc safety infusion set with y-site.Usage residues were observed throughout the sample.A needleless injection cap was attached to the y-site.A crack was observed in the y-site, extending from the luer orifice nearly to the mold cavity marking.Microscopic inspection of the sample revealed a granular fracture surface.The split occurred along the molding weld line.The crack in the y-site occurred along a weld line feature introduced during the component molding process.Attempts to replicate the crack using non-complainant devices suggested that the crack occurred due to a combination of mechanical stress and cleaning chemical exposure at the site of the weld line.The complaint sample is a supplied component and the supplier has been notified of this event.Corrective actions have been implemented by the supplier and the complaint sample was manufactured prior to implementation of any corrective actions.A lot history review (lhr) of asdvf039 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the patient was accessed on (b)(6) 2020 and sent home with port accessed (heparin locked per institution policy).Upon checking port needle a crack was noted on (b)(6) 2020.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN 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: 10055619
• Report Number: 3006260740-2020-01735
• Device Sequence Number: 19548563
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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: 08/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 0682034
• Device Lot Number: ASDVF039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 142