MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X .0.75"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the connection site separated during the 1st flush.No other information was provided.
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 crack in the connector was confirmed, but the exact cause was unknown.One 20g huber plus infusion set was returned for investigation.The infusion set exhibited evidence of use.The clamp was closed over the extension set tubing.Blood residue was visible within the extension set tubing.The safety mechanism had been activated.A longitudinal crack was observed in the connector.The crack was 1.3cm in length.The crack was observed 180-degrees from the injection gate site on the connector.The crack site was circled with black ink.Gross visual and microscopic examinations and functional testing showed no evidence of a defect or deformity related to the manufacturing process.It appeared that the complaint sample was damaged during use; however, based on the evidence provided with the returned sample, it is unknown what caused the luer to crack.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 separated during the 1st flush.No other information was provided.

• 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: 8215366
• Report Number: 3006260740-2018-03804
• Device Sequence Number: 16542389
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 02/07/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1