MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X .0.75"; 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	02/17/2020
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the connection site between hub and set was found to be leaking.
Event or Problem Description
It was reported that the connection site between hub and set was found to be leaking.
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 a leaking infusion set was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 0.75¿ huber plus safety infusion set.Usage residues were observed throughout the sample.Usage residues were observed throughout the sample and the safety mechanism was engaged.A longitudinally aligned split was observed in the luer adapter.The split occurred between the proximal orifice and the finger tabs.Microscopic inspection of the split revealed a granular fracture surface.Discoloration was in the vicinity of the split.The split appeared to occur along the molding weld line.Inspection of the threads was unremarkable.The split characteristics were consistent with separation of the luer material along the molding weld line; however, attempts to replicate the failure were unsuccessful, suggesting that an additional unidentified factor(s) contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include forceful insertion of a tapered object and environmental factors affecting material properties.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: HUBER PLUS 20G X .0.75"
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9823571
• Report Number: 3006260740-2020-00823
• Device Sequence Number: 19615485
• Product Code: FPA
• UDI-Device Identifier: 00801741065620
• UDI-Public: (01)00801741065620
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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 Model Number: N/A
• Device Catalogue Number: 012034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1