MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PPICC SV 3F SL,BASIC, CE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

It was reported picc power 3 fr.Ultrasound-guided positioning on (b)(6) 2022 in the left brachial/humeral vein.Without technical difficulties reported by the implanter and subsequent execution of ct with contrast medium.On 20/12, [patient] went to the oncology department to start chemotherapy treatment with taxol.At the start of the infusion, the patient feels sharp pain and the procedure is stopped.At the tav clinic, only a small hematoma was found at the catheter insertion point.Ultrasound diagnostics does not show thrombosis or displacement of the catheter present inside the vascular lumen.Ultrasound and physiological contrast medium is injected and the presence of the injected outside the catheter inside the vascular lumen is highlighted.The entire catheter is gently withdrawn under ultrasound guidance.By injecting saline, it breaks in 2-3 points about 10 cm from the cone.Consequence: specific intervention.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refr1459 showed no other similar product complaint(s) from this lot number.

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, applicable previous investigation(s), sample analysis, complaint and lot history review, 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 body was confirmed.The product returned for evaluation was 3fr sl powerpicc sv catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a split was observed between the 6 and 8cm marks on the catheter tubing.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.The short time frame between the insertion date and the date of discovery suggests this damage likely occurred during insertion.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.

Event Description

It was reported picc power 3 fr.Ultrasound-guided positioning on (b)(6) 2022 in the left brachial/humeral vein.Without technical difficulties reported by the implanter and subsequent execution of ct with contrast medium.On 20/12, [patient] went to the oncology department to start chemotherapy treatment with taxol.At the start of the infusion, the patient feels sharp pain and the procedure is stopped.At the tav clinic, only a small hematoma was found at the catheter insertion point.Ultrasound diagnostics does not show thrombosis or displacement of the catheter present inside the vascular lumen.Ultrasound and physiological contrast medium is injected and the presence of the injected outside the catheter inside the vascular lumen is highlighted.The entire catheter is gently withdrawn under ultrasound guidance.By injecting saline, it breaks in 2-3 points about 10 cm from the cone.Consequence: specific intervention.

• Brand Name: PPICC SV 3F SL,BASIC, CE
• 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: 16216929
• MDR Text Key: 308164727
• Report Number: 3006260740-2023-00080
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102159
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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: 66173118
• Device Lot Number: REFR1459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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