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

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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)(6) facility.

Event Description

It was reported that the packaging was not completely sealed around the edge.Device was not used on patient.This reported addresses device thirty-seven.

Manufacturer Narrative

Initial medwatch was created in error.The device failure is exempt from mdr reporting per 21 crf803.19 reference (b)(4) and will be reported on alternative summary report.

Event Description

It was reported that the packaging was not completely sealed around the edge.Device was not used on patient.This reported addresses device thirty-seven.

• Brand Name: EZ HUBER 19G X 19MM
• Type of Device: ADMINISTRATION INTRAVASCULAR SET
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6648373
• MDR Text Key: 77941702
• Report Number: 3006260740-2017-00854
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741089138
• UDI-Public: (01)00801741089138(17)180228(10)REZC0751
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1