MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported piccline inserted (b)(6) 2022.On admission, length of visible catheter part 0 cm.Patient managed by asih at home, using piccline for tpn.Asih has to go out on an emergency visit in the middle of the night at 02 when patient hears that there is a leak from the piccline, the shirt completely wet from tpn when the nurse arrives.Upon inspection, nurse sees a leak just above the "butterfly" (the part where the statlock are attached) where it merges into the hose.When flushing, most of it continues up into the picc catheter, but a few drops seep out.Only 200ml of the tpn has gone in.Piccline is reset, tpn is disconnected.They contact the piccline nurse the next day and a decision is made to discontinue the piccline, which is done on (b)(6) 2022.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refy1019 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported piccline inserted (b)(6) 2022.On admission, length of visible catheter part 0 cm.Patient managed by asih at home, using piccline for tpn.Asih has to go out on an emergency visit in the middle of the night at 02 when patient hears that there is a leak from the piccline, the shirt completely wet from tpn when the nurse arrives.Upon inspection, nurse sees a leak just above the "butterfly" (the part where the statlock are attached) where it merges into the hose.When flushing, most of it continues up into the picc catheter, but a few drops seep out.Only 200ml of the tpn has gone in.Piccline is reset, tpn is disconnected.They contact the piccline nurse the next day and a decision is made to discontinue the piccline, which is done on (b)(6) 2022.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, sample analysis, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the catheter is confirmed and was determined to be caused by kinking of the catheter.One 4 fr s/l powerpicc solo catheter with a needleless injection cap attached was returned for evaluation.An initial visual observation showed use residues throughout the catheter and adhesive on the molded joint from the securement process.During a functional test using water in a 12 ml syringe and attaching it to the luer of the catheter, the catheter was patent to infusion.After the catheter was pressurized, a leak was found just distal of the molded joint.A microscopic observation revealed whitening around the edges of the split and a granular fracture surface.Buckling and discoloration was observed along the fracture surface.Circumferentially aligned markings were observed opposite the split site.Based on the observations of the returned powerpicc catheter, the complaint of a leaking catheter was confirmed and is likely due to excessive kinking of the catheter.This can occur if the securement of the catheter causes a sharp kink, and over a period of time the catheter may fail opposite of the kink impression.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15973995
• MDR Text Key: 307686191
• Report Number: 3006260740-2022-05708
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Device Lot Number: REFY1019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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