MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 4F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 70CM NITINOL GUIDEWIRE); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/09/2017

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebs0014 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.

Event Description

It was reported that the valve was not sealed.No other information was provided.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 bleedback through the solo valve was inconclusive since the clinical conditions could not be replicated.The product returned for evaluation was a 4fr s/l powerpicc solo catheter.The sample contained light traces of usage residue and had been trimmed near the 45cm depth marking.Gross visual evaluation of the catheter, and specific visual examination of the solo valve/luer connector, was unremarkable.Examination of the condition of the valve was performed with the aid of a lighted microscope and the valve was found to be appropriately seated within the connector and appeared to be appropriately manufactured.No evidence of residue caught within the valve slits, or other potential cause of an open valve, was observed.The sample was found to be patent to aspiration and infusion, and the valve position was noted to be normal following flow testing.No condition was observed during the investigation that could have contributed towards the event, but the exact conditions involved in the event could not be duplicated.The maintenance guide provided with the product advises to use a ¿stop/start¿, or pulse, technique when flushing which can correct this type of event.A lot history review (lhr) of rebs0014 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the valve was not sealed.No other information was provided.No reported patient injury.11/21/2017- additional information from contact stated: "the valve is not waterproof.As soon as the procedure is in place, there is a blood reflux without any intervention on the part of the radiologist".

• Brand Name: POWERPICC SOLO 4F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 70CM NITINOL GUIDEWIRE)
• 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: 6993766
• MDR Text Key: 91294318
• Report Number: 3006260740-2017-01936
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139079
• UDI-Public: (01)00801741139079
• Combination Product (y/n): N
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6194355
• Device Lot Number: REBS0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/12/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 116