MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,PFLEX 20G 8CM FULL; INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Positioning Failure (1158); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/29/2016

Event Type  Injury  

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, as the device is being retained by the reporting facility.A lot history review (lhr) of reau1896 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by bas clinical specialist that she was at the facility training when the alleged failure occurred.While inserting the powerglide into the left brachial vein, the guidewire was inserted, the catheter was deployed, and when the housing unit was removed it was reported that the guidewire was sheared.Clinical specialist stated that the needle retracted into the safety device and the catheter was then removed.It was found under x-ray and ultrasound that a piece of the guidewire remained in the patient.Patient was sent to interventional radiology for removal.

• Brand Name: DOT,PFLEX 20G 8CM FULL
• Type of Device: 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6183552
• MDR Text Key: 62679004
• Report Number: 3006260740-2016-00689
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110672
• UDI-Public: (01)00801741110672(17)180131(10)REAU1896
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: F220081
• Device Lot Number: REAU1896
• 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: 07/01/2016
• 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
• Patient Outcome(s): Required Intervention