MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Chest Tightness/Pressure (2463)

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) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

The patient reported that she got a picc inserted and after insertion felt intense pressure in chest on the side of the picc line along with difficulty breathing.Patient stated that within maybe one or two hours, she got up and the picc bled all over the hospital room floor, patient grabbed a towel and applied pressure to stop the bleeding.Patient said that about 1/2 hour later, i went to the bathroom with my i.V.Pole, and started bleeding everywhere, grabbed a bed pad to hold pressure, and noticed there was no picc line.The patient stated the fell out and was on the floor.She expressed that she no longer felt the pain and could breathe well again.

• Brand Name: PICC
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7470820
• MDR Text Key: 106890381
• Report Number: 3006260740-2018-00858
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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