MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5 FR DL POWERPICC, RADIOLOGY 135 CM NITINOL WIRE; PERCUTANEOUS, IMPLANTED LONT TERM INTRAVASCULAR CATHETER

Model Number 3275335

Device Problem Uncoiled (1659)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2017

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 rebr0386 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (rebr0386) have been reported from the same facility.

Event Description

It was reported by the facility that when the kit was opened the guidewire appeared to be uncoiled, "the floppy end is twice as long as it is supposed to be".Device was not used on patient.

• Brand Name: 5 FR DL POWERPICC, RADIOLOGY 135 CM NITINOL WIRE
• Type of Device: PERCUTANEOUS, IMPLANTED LONT TERM INTRAVASCULAR CATHETER
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6866088
• MDR Text Key: 87318179
• Report Number: 3006260740-2017-01611
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3275335
• Device Catalogue Number: 3275335
• Device Lot Number: REBR0386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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