MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Foreign Body Reaction (1868)

Event Date 06/13/2022

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 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.

Event Description

It was reported by healthcare professional "skin reaction during picc placement.Placed a picc completely uncomplicated.When i was going to attach the statlock, i see that patient got a swelling along the vessel just the length of the introducer (which was gone).There was never any redness but only as an elevation, as when you have a mosquito bite that is extra irritated.It was really exactly the same length and came very suddenly and really looked like the introducer was still stuck under the skin.Then got a rash higher up on the arm about 2x2 cm.That area was not near where the picc was located but further down the table.Also got redness from the tape.Pat stated that she did not have any contact allergies that she knew about.We removed picc in consultation with doctor.Should send patient to the allergy clinic.".

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG
• 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: 14860706
• MDR Text Key: 295033209
• Report Number: 3006260740-2022-02460
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• 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: 2194108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• 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): Required Intervention