MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 19G X 19MM; ADMINISTRATION INTRAVASCULAR SET

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rezc0751 showed 41 other similar product complaint(s) from this lot number.The complaints for this lot number (reax1618) have been reported from the same (b)(4) facility.
Event or Problem Description
It was reported that the packaging was not completely sealed around the edge.Device was not used on patient.This reported addresses device forty-two.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bard 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 bard.Initial medwatch was created in error.The device failure is exempt from mdr reporting per 21 crf803.19 reference e1997041 and will be reported on alternative summary report.
Event or Problem Description
It was reported that the packaging was not completely sealed around the edge.Device was not used on patient.This reported addresses device forty-two.

• Brand Name: EZ HUBER 19G X 19MM
• Common Device Name: ADMINISTRATION INTRAVASCULAR SET
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6648396
• Report Number: 3006260740-2017-00859
• Device Sequence Number: 1285934
• Product Code: FPA
• UDI-Device Identifier: 00801741089138
• UDI-Public: (01)00801741089138(17)180228(10)REZC0751
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: SHG19-75
• Device Lot Number: REZC0751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1