MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 18G 10CM BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Defective Device (2588)

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

Event Type  malfunction  

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 damaged ''powerglide'' pro assembly was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a portion of ''powerglide'' midline catheter assembly.The visible portion of the device included the distal end of the needle and catheter.The catheter overlaid the needle.The guidewire protruded from the needle.A kink was visible in the guidewire near the exit site form the needle.The distal end of the guidewire was not visible in the photograph.While guidewire damage was evident in the submitted photograph, inspection of the image was insufficient to identify the root cause of that damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include attempted guidewire advancement into issue and device manipulation.A lot history review (lhr) of recw1304 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that vat nurse went to place an edc on a patient and the edc "was not functioning correctly" and the line was removed.No patient harm was reported.

• Brand Name: PG PRO 18G 10CM BASIC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: 8444600
• MDR Text Key: 140423780
• Report Number: 3006260740-2019-00627
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• 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: distributor,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: F118100
• Device Lot Number: RECW1304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Event Location: Hospital
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• 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