MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 6F FULL TRAY (TL); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Fracture (1260); Kinked (1339)

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

Event Date 06/09/2017

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 evaluate.Results are expected soon.A lot history review (lhr) of reat0103 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the picc fractured 3 cm external to the patient.The picc was said to have been kinked.The patient was not harmed.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 6fr t/l powerpicc solo catheter.The catheter terminated at the 41cm depth marking.Usage residues were observed throughout the sample.A permanent kink impression was observed between the 3cm and 4cm depth markings.A diagonally aligned split was observed along the corner of the kink impression.The sample kinked preferentially at the kink impression site during manual manipulation.Microscopic inspection of sample confirmed the presence of a deep permanent kink impression.The catheter exhibited permanent deformation at the kink site.Material buckling and wear were observed in the vicinity of the split.The split characteristics and accompanying deformation/preferential kinking were consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors gradually form a crack in the catheter.The location of the damage suggested that catheter placement/securement may have contributed to the damage.

Event Description

It was reported the picc fractured 3cm external to the patient.The picc was said to have been kinked.The patient was not harmed.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 6F FULL TRAY (TL)
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6680236
• MDR Text Key: 78908088
• Report Number: 3006260740-2017-00948
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741140051
• UDI-Public: (01)00801741140051
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 2396108
• Device Lot Number: REAT0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/20/2017
• 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