MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Extravasation (1842); Swelling/ Edema (4577)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regu1678 showed no other similar product othcomplaint(s) from this lot number.

Event Description

It was reported by the customer, "received a call from our oncology dept.Regarding extravasation of a picc line that was inserted on (b)(6) 2023.The patient received 600ml of chemotherapeutic agent and noted moderated swelling on right forearm at least 1-2cm below puncture site.Rn pulled the picc after discussion with oncology md.The picc was 1 cm out from the puncture site and the area where it was leaking was at 2.5cm mark".

• Brand Name: POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16420186
• MDR Text Key: 310007145
• Report Number: 3006260740-2023-00503
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1194108D5
• Device Lot Number: REGU1678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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): Other