MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problems Chest Pain (1776); Cardiac Perforation (2513); Foreign Body In Patient (2687)

Event Date 10/28/2021

Event Type  Injury  

Manufacturer Narrative

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, "breakage of the catheter guide in the pediatric sector of the hospital, the guide remained in the child for 20 days, perforating the mediastinum, requiring cardiac surgery.".

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, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged wire was confirmed, but the exact cause could not be determined from the photograph and video that were provided for investigation.The photograph showed what appeared to be an incomplete guidewire.What appeared to be the floppy tip was visible at one end of the guidewire.The video that was provided for investigation showed what appeared to be the guidewire segment from the photograph held alongside another guidewire that was longer and extended from the guidewire hoop.The user attempted to cut the longer wire with scissors, but the wire could not be cut with the scissors.Since the side by side comparison in the video showed a shortened segment of guidewire, the complaint was confirmed, but the exact cause of the reported event and damage could not be determined from the provided photograph and video.H3 other text : evaluation findings are in section h11.

Event Description

It was reported, "breakage of the catheter guide in the pediatric sector of the hospital, the guide remained in the child for 20 days, perforating the mediastinum, requiring cardiac surgery." additional information stated: "an event occurred in the unit with a 13-year-old teenager.A piece of the guide had remained inside the patient who had been discharged from the hospital and returned days later to the unit with chest discomfort, performing some imaging tests that confirmed the presence of the artifact, thus generating the need for thoracic surgery in the adolescent to remove this artifact.I requested access to x-ray images and reports of the initial procedure of passing the picc by inserting nurses, and we realized that the unit did not have a protocol being applied properly, there was no post-procedure follow-up, and there was no validation document for the qualification of this inserting professional.The part of the guide taken from the teenager is in the possession of his mother.".

• Brand Name: POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN)
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12839965
• MDR Text Key: 281028272
• Report Number: 3006260740-2021-04944
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3275118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• 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: 13 YR
• Patient Sex: Male