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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recw0616 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recw0616) have been reported from the same facility in brazil.Device not yet received.

Event Description

It was reported that a patient with pulmonary hypertension and using antibiotics and vasoactive drugs had the catheter picc placed on (b)(6) 2019 and removed on (b)(6) 2019 due to obstruction.

Event Description

It was reported that a patient with pulmonary hypertension and using antibiotics and vasoactive drugs had the catheter picc placed on (b)(6) 2019 and removed on (b)(6) 2019 due to obstruction.

Manufacturer Narrative

The information provided by bd 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 bd.On 5/16/2019 - the following were reviewed as part of this investigation: sample evaluation, patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an occluded catheter was confirmed and the cause was determined to be use related.The product returned for evaluation was a 5fr d/l powerpicc catheter.The sample contained usage residue throughout.Sticky dressing residue was seen on the extension legs through the 4cm depth marking and blood residue was seen within the extension legs and catheter shaft.Further evaluation of the device found a dark red residue within the distal tip of the catheter.Microscopic examination of the tip confirmed that it had the appearance of dried blood.Functional testing confirmed that both lumens were completely occluded.The complainant had indicated, within the event description, that the catheter was used for near two weeks between insertion and removal which suggested the catheter had originally worked as intended.No potential manufacture cause to the event was observed.

• Brand Name: POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN)
• 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
• MDR Report Key: 8549853
• MDR Text Key: 143717887
• Report Number: 3006260740-2019-01146
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027918
• UDI-Public: (01)00801741027918
• Combination Product (y/n): N
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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: 3275118
• Device Lot Number: RECW0616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 84