MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 GROSHONG MID LINE MINI TRAY 4F; CATHETER, INTRAVASCULAR, THERAPEUTIC, LESS THAN 30 DAYS

Catalog Number 7715435CE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Date 06/21/2015

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.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from these lot numbers.The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.

Event Description

Reportedly, that during a procedure for intravenous therapy in a cardiopathic and diabetic patient.During the control and after 5 days, they noted that the catheter allegedly migrated in pulmonary artery.The alleged migrated catheter was supposedly, not removed from the patient due to the general bad condition of the patient.Reportedly, the cardiologist and the radiologist of the hospital were consulted and they reportedly suggested not removing the catheter due to critical clinical conditions.It is said that the patient is not experiencing symptoms related to the alleged migrated catheter.

• Brand Name: GROSHONG MID LINE MINI TRAY 4F
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LESS THAN 30 DAYS
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; 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 n. 5600 w.; salt lake city, UT 84116 ; 8015225631
• MDR Report Key: 5005380
• MDR Text Key: 23087391
• Report Number: 3006260740-2015-00360
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K871080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 07/20/2015

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 Expiration Date: 09/30/2019
• Device Catalogue Number: 7715435CE
• Device Lot Number: REYI2543
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 74