MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET BASIC TRAY (30 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 4132105

Device Problems Migration or Expulsion of Device (1395); Device-Device Incompatibility (2919)

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

Event Date 02/09/2018

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, as the device was discarded after the event occurred.A lot history review (lhr) of rebt0803 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebt0803) have been reported from the same (b)(6) facility.

Event Description

During catheter placement, in all the veins that were punctured, the catheter was migrating when reaching around 9 centimeters.By the time the catheter was withdrawal, it was noticed that the guide wire had perforated the catheter.However the correct technique was done by keeping one centimeter drawn.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET BASIC TRAY (30 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7324386
• MDR Text Key: 102000155
• Report Number: 3006260740-2018-00399
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074837
• UDI-Public: (01)00801741074837
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 4132105
• Device Catalogue Number: 4132105
• Device Lot Number: REBT0803
• 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: 06/01/2017
• 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