MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F BASIC TRAY; 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 Skin Erosion (2075); Thrombus (2101)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of clotting and skin breakdown due to an inserted picc cannot be confirmed due to the condition of the sample, as well as unknown clinical conditions.The sample returned consisted of four photographs, apparently of a patient.Visual observation found that the photographs showed a lesion of some kind, wherein redness and the appearance of a bruise or similar was evident.The skin appeared wrinkled in the area of this lesion and some of the top layer of skin appeared to have come off.No catheter was present in any of the photographs.One of the photographs showed an area of skin which was apparently not affected like the area of skin shown in the other photographs.However, blood vessels were visible and appeared to be raised.Although a lesion was found depicted in the returned photographs, no link can be objectively determined between the catheter and this patient condition with the photographs and evidence available.The complaint therefore cannot be confirmed.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.The ifu states the following: "possible complications: ¿hematoma: hypersensitivity, anaphylactic or anaphylactic-like reaction during placement1, positioning1, flushing2 of catheter or cleaning of catheter exit site3.Intolerance reaction to implanted device perforation of vessels or viscus.Phlebitis.Venous thrombosis: risks normally associated with local or general anesthesia, surgery, and post-operative recovery.¿ ¿contraindications: the device is contraindicated whenever: the patient is known or is suspected to be allergic to materials contained in the device.Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.Local tissue factors will prevent proper device stabilization and/or access.¿ a lot history review (lhr) of rebs1605 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the patient had picc placed on (b)(6) 2017, and removed on (b)(6) 2017, due to clot and break down of the skin.The picc was removed and the patient had it replaced with a powerglide.It was stated the patient may be reacting to the material in the line.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F BASIC TRAY
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7260472
• MDR Text Key: 99604407
• Report Number: 3006260740-2018-00174
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• 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: 1295118
• Device Lot Number: REBS1605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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