MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DUAL-LUMEN CATHETER BASIC TRAY (NITINOL GUIDEWIRE 70CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 8275355

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/27/2017

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 rebu1382 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that catheter was found filtering in its external part after being implanted.No patient injury reported.

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 leak is confirmed and was determined to be use related.One 5 fr dual lumen powerpicc was returned for evaluation.An initial visual observation showed a small, curved split just distal to the bifurcation.A microscopic observation revealed some use residue on the sample.The split was observed to be ¿v¿-shaped and the edges of the split were observed to be jagged but defined.Striations were observed on the fracture surface of the split which indicate the sample was cut with a ground-sharpened instrument.A lot history review (lhr) cannot be performed as the lot number provided by the complainant was found to be inconsistent with the returned product and the item number provided.

Event Description

It was reported that catheter was found filtering in its external part after being implanted.No patient injury reported.

• Brand Name: POWERPICC 5F DUAL-LUMEN CATHETER BASIC TRAY (NITINOL GUIDEWIRE 70CM)
• 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: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 7087636
• MDR Text Key: 94143181
• Report Number: 3006260740-2017-02178
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139925
• UDI-Public: (01)00801741139925
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8275355
• Device Lot Number: REBU_1382 (INCORRECT)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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