MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROVENA PPICC, 3F SL, MAX 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number S1173108D

Device Problems Kinked (1339); No Flow (2991)

Patient Problem No Code Available (3191)

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 for evaluation.A lot history review (lhr) of rebto240 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to sales rep that the picc was placed without difficulty and was functioning adequately upon patient discharge.After 3 days the patient returned to er with c/o picc not flushing.Van team members troubleshooted and were also not able to flush.Cxr showed that picc catheter and tip were displaced with what appeared to be a ¿knot/kink¿ in brachiocephalic.Van was instructed to remove picc but unable to do so.Patient was sent to ir for removal.At this time no procedural note is noted.Therefore course of action taken is undetermined.

• Brand Name: PROVENA PPICC, 3F SL, MAX 3CG
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7020789
• MDR Text Key: 92916260
• Report Number: 3006260740-2017-02004
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741130342
• UDI-Public: (01)00801741130342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162443
• 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
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: S1173108D
• Device Lot Number: REBTO240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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