MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 2194108

Device Problem Aspiration Issue (2883)

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

Event Date 02/28/2018

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 evaluate.Results are expected soon.A lot history review (lhr) of reby1857 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the picc line was placed (b)(6) 2018.The nurse was unable to flush or aspirate the picc unless the patient¿s arm was positioned ¿with flexion at the elbow.¿ the nurse then withdrew the picc until it flushed and aspirated without difficulty.A chest x-ray showed the picc was at the junction of the patient¿s svc/innominate vein and the picc was removed on (b)(6) 2018.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 catheter kink is confirmed to be use related.One 4f powerpicc solo with a needleless injection cap was returned for investigation.The catheter extended 56 cm from the 0 depth marker.Kinks were observed at the 7cm and between the 10 and 11 depth markers.Microscopic evaluation revealed nothing remarkable.The returned sample was flushed with water using a 12 ml syringe and was found to be patent to infusion.No leaks were observed during pressurization.Based on the description of the reported event and condition of the returned sample, a likely cause of the catheter kinking appears to be related to the use and placement of the device; therefore, the complaint of a catheter kink is confirmed to be use related.The ifu states ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ a lot history review (lhr) of reby1857 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the picc line was placed (b)(6) 2018.The nurse was unable to flush or aspirate the picc unless the patient¿s arm was positioned ¿with flexion at the elbow.¿ the nurse then withdrew the picc until it flushed and aspirated without difficulty.A chest x-ray showed the picc was at the junction of the patient¿s svc/innominate vein and the picc was removed on (b)(6) 2018.There was no reported patient injury.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7366696
• MDR Text Key: 103549395
• Report Number: 3006260740-2018-00514
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741138973
• UDI-Public: (01)00801741138973
• Combination Product (y/n): N
• Reporter Country Code: BC
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2194108
• Device Lot Number: REBY1857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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