MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE

Catalog Number 3174118

Device Problems Break (1069); Retraction Problem (1536)

Patient Problem Embolism (1829)

Event Type  Injury  

Event Description

It was reported "the patient was allegedly found to be bleeding from the picc site arm and a segment of the power picc approximately 11 cm to the end of the hub had been reportedly broken free from the remainder of the powerpicc.It was stated the remainder of the picc had retracted back into the vein and reportedly none of the picc catheter was exposed from the picc insertion site.The patient was urgently xrayed which allegedly showed the retracted powerpicc segment in the right atrium and transferred to the operating theatres.It was reported the retracted powerpicc segment was retrieved via cut down by a vascular surgeon.".

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reyi0905 showed no other similar product complaint(s) from these lot numbers.

• Brand Name: POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; reynosa, tamaulipas ; MX
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116-0000 ; 8015224969
• MDR Report Key: 4585065
• MDR Text Key: 16864036
• Report Number: 3006260740-2015-00109
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3174118
• Device Lot Number: REYI0905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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