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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2020

Event Type  malfunction  

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 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.Device not returned for evaluation.

Event Description

It was reported via ms&s "doctor concerned patient has retained portion of picc after removal.Chest x-ray shows area of unknown density he is concerned about near rib curvature and he is considering atelectasis or possibly migration of a portion of the picc.Dr.Does not have reference or lot number for picc but states it is 5f tl power picc.Dr.Is asking what the length before cut is for the picc and if it is radiopaque.Dr.Will consult with radiology to further review x-ray.Follow up call-dr.States he spoke with radiology and they do not feel there is evidence of retained picc portion or catheter fracture.Ms&s responded: informed the powerpicc alone does not come in 5f tl however we have some powerpicc's with additions to the name powerpicc that are 5f tl and they are all 55cm in length before trimmed and are radiopaque.Follow up called doctor back to suggest re-measuring patient for picc length related to clinically deducting.Add info rcvd (b)(6) 2020 - there was not a relevant adverse event.The patient accidentally removed the catheter while rolling over in bed.There was no need for replacement of the catheter as his course of treatment had completed that day and was due to have it removed by the placing facility later that day.No issues after evaluation and no catheter malfunction/ fragmentation noted.

• Brand Name: POWERPICC 5F TRIPLE-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: 10995958
• MDR Text Key: 221770796
• Report Number: 3006260740-2020-20895
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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