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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Perforation of Vessels (2135)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the patient had a powerpicc implanted via the left upper arm on (b)(6) 2022.On (b)(6) 2022, when the examination was performed because the patient complained of chest pain, it was confirmed that the vessel was perforated and mediastinal tumor occurred.There was no reported patient injury.

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), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a vascular perforations could not be confirmed due to poor sample condition.One 5 fr dl powerpicc catheter was returned for evaluation.The catheter was trimmed between the 42 and 43 cm depth marker.The trimmed catheter tip did not appear to be even.Microscopic inspection of the catheter tip revealed two non-planar edges.One of the edges contained a sharply formed feature.The characteristics of the trimmed region suggest that the features may have been created during the trimming process; however, it could not be confirmed that this abnormal catheter tip was directly responsible for the patient condition as no medical records were available to assess the condition, features, and circumstances of the reported patient condition.Although there was an abnormal edge to the trimmed catheter tip, it couldn't be confirmed that this abnormality, by itself, could cause that condition.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the patient had a powerpicc implanted via the left upper arm on (b)(6) 2022.On (b)(6) 2022, when the examination was performed because the patient complained of chest pain, it was confirmed that the vessel was perforated and mediastinal tumor occurred.There was no reported patient injury.

• Brand Name: PPICC BASIC
• 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: 16098635
• MDR Text Key: 306656876
• Report Number: 3006260740-2022-05980
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051672
• 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,Followup
• Report Date: 01/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3275118J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 81 YR
• Patient Sex: Female