MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4FR SL GROSHONG 3CG BASIC; PERIPHERALLY-INSERTED CENTRAL VENOUS CATHETER

Model Number N/A

Device Problems Hole In Material (1293); Malposition of Device (2616)

Patient Problems Extravasation (1842); Pain (1994); Swelling (2091)

Event Date 04/10/2017

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, at this time, for evaluation.A lot history review (lhr) of reav0416 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during chemotherapy infusion the patient noted swelling near the insertion site of the catheter and felt pain, indicated an extravasation.Catheter was removed and it was stated that a there was a hole 2 cm near the insertion point.Informed the (b)(6) of incident.

• Brand Name: 4FR SL GROSHONG 3CG BASIC
• Type of Device: PERIPHERALLY-INSERTED CENTRAL VENOUS CATHETER
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6543953
• MDR Text Key: 74597675
• Report Number: 3006260740-2017-00562
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741107825
• UDI-Public: (01)00801741107825(17)170828(10)REAV0416
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: 801(E)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 91660417
• Device Lot Number: REAV0416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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 Age: 56 YR