MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 4 FR SL WITH SHERLOCK 3CG STYLET; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number 1194118

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reat1377 showed no other similar product complaint(s) from this lot number.Results are expected soon.

Event Description

It was reported that on (b)(6) 2017 a small split in the picc was observed when flushing the line.There was no reported patient injury.

Manufacturer Narrative

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 a split powerpicc is confirmed, and the cause appears use-related.Visual observation found that the lettering on the extension leg was somewhat worn away and that the leg manifested a small amount adhesive residue on the outside.There were two holes in the catheter, one between the 6-cmand 7-cm depth marks, and one between the 7-cm and 8-cm depth marks.The holes were not positioned along the same side of the catheter.Most depth marks from 0 cm to 6 cm were partially missing.The holes were roughly transverse but at diagonals to the axis of the catheter.All depth marks from 0 cm to 54 cm were present, and the catheter length did not appear to be altered.Tensile weakness was noted in the catheter tubing.Microscopic observation found the break surfaces at both holes to be highly granular, and that whitening was present at the two ends of each hole.The distal tip appeared smooth, straight, and striated.Tactual evaluation found clear preferential kinking at both hole sites when bending both toward and away from each hole.A preferential kink site was reproduced upon grasping the catheter in two hands and moving those two points back and forth repeatedly.The preferential kinking and whitening with nearly perpendicular hole with granular break surface is consistent with cyclic kinking resulting in eventual breakage.Functional testing found a leak at the holes during infusion.A memo included with the device stated that the picc line was located in the patient¿s left brachial vein and was noted to be leaking during dressing and routine care.The skin under the dressing was intact and no phlebitis was present.The mark at skin was reported to be the 11 cm mark and the picc length was reported to be 55 cm.This signifies that a significant amount of the catheter was outside of the patient and would need to be dressed with special care to prevent injury to the device.It is apparent that the portion of the catheter outside the body experienced excessive repeated mechanical stress.It should also be noted that certain chemicals, such as acetone and tincture of iodine, as well as excessive contact with alcohol-containing solutions, can degrade the catheter, making it more susceptible to damage.The memo also stated that ¿line proved difficult to remove, exiting only 30cm before effort abandoned by nurse carer, and the patient was referred to local hospital for this removal to be completed.Line was inserted (b)(6) 2017¿.(b)(6) 2017 picc removed.¿ this complaint of difficulty of removal will be addressed in complaint (b)(4).The following statements from instructions for use documents may be of assistance: from the patient guide; ¿11.Some facilities place a securement device at this point.Check with your nurse or doctor to see if this pertains to your picc.Fold a 2 in.X 2 in.Gauze in half and place it under the catheter hub for padding (if needed), and apply tape strips.Check to see that the catheter is not kinked or pinched.Apply the cover dressing centering it over the insertion site, following the directions in the package as well as instructions.From your doctor or nurse.Secure the catheter to the dressing or arm with tape.This will prevent pulling of the catheter at the insertion site and decrease irritation.To help prevent possible catheter occlusion, coiling the catheter is not recommended.Always secure the catheter in such a way that you can easily see the cap end.Your doctor or nurse will help you select the best method to secure the catheter.The type of clothing and normal activity will need to be considered in this procedure.You should periodically look at the capped end to be sure it is intact.¿ from the nursing ifu: ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ ¿avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.¿.

Event Description

It was reported that on (b)(6) 2017 a small split in the picc was observed when flushing the line.There was no reported patient injury.

• Brand Name: POWERPICC SOLO 4 FR SL WITH SHERLOCK 3CG STYLET
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6758984
• MDR Text Key: 81720286
• Report Number: 3006260740-2017-01196
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034527
• UDI-Public: (01)00801741034527
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 1194118
• Device Catalogue Number: 1194118
• Device Lot Number: REAT1377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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