MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 22G X 25MM WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	Chemical Exposure (2570)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 leaking infusion set was inconclusive because the implicated device was not returned for evaluation.The product returned for evaluation was one 22ga x 1¿ ez huber safety infusion set.The sample was received in its original sealed packaging.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization of the sample.Microscopic inspection of the sample was unremarkable.No deficiencies were discovered during evaluation of the returned sample; however, the sealed and unused state of the returned sample indicated that it was not the device implicated by the complainant.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of rect0218 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the ez huber needle leaked at the y-site onto the patient during the administration of chemotherapy.

• Brand Name: EZ HUBER 22G X 25MM 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: 8341214
• Report Number: 3006260740-2019-00271
• Device Sequence Number: 2253956
• Product Code: FPA
• UDI-Device Identifier: 00801741089275
• UDI-Public: (01)00801741089275
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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: SHG22-100Y
• Device Lot Number: RECT0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1