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

Model Number N/A

Device Problems Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

It was reported "the nurse had the picc line inserted in the patient and when she went to remove the guidewire, it appeared to be ¿stretching¿ and getting thinner.It appeared that the wire was somehow coiled inside the line itself.The initial line was removed and replaced, without harm to the patient.".

Manufacturer Narrative

The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

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, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is confirmed.One 5 fr dual lumen powerpicc solo catheter with a t-lock and stiffening stylet inserted was returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.The core wire of the stylet was observed to be broken with the majority of the coiled wire proximal to the t-lock found to be unraveled.The distal end of the stylet was observed to remain within the red lumen of the catheter.A microscopic observation revealed the fracture site of the core wire to be angled and lustrous with linear striations leading up to the peak of the break.Once the distal end of the stylet was removed from the catheter, it was found that the distal tip was broken off and missing.The break site of the coiled wire was observed to be mostly flat and smooth and was noted to end abruptly and distal to a tightly coiled section of the wire.The observed characteristics of the break sites in the returned stylet are indicative of damage caused by a sharp instrument such as scissors.A lot history review (lhr) of refx4402 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "the nurse had the picc line inserted in the patient and when she went to remove the guidewire, it appeared to be ¿stretching¿ and getting thinner.It appeared that the wire was somehow coiled inside the line itself.The initial line was removed and replaced, without harm to the patient.".

• Brand Name: POWERPICC SOLO FT CATHETER 5F FULL TRAY (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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14518017
• MDR Text Key: 292792204
• Report Number: 3006260740-2022-01965
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

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 Model Number: N/A
• Device Catalogue Number: 3295108D
• Device Lot Number: REFX4402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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