MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number 1275108D

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

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

Event Date 12/19/2017

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 for evaluation.A lot history review (lhr) of rebx2497 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (rebx2497) have been reported from the same facility.

Event Description

It was reported by the sales rep that the facility reported having a picc wire that would not display the yellow 3cg rhythm.They stated the rhythm line was either flat-line or squared off artifact.They also stated that sometimes the rhythm would show up of they held the picc wire at just the right spot or manipulated it.The sales rep stated that chest x-rays were used to verify tip location.There was no reported patient injury.

Manufacturer Narrative

Upon further review it was found that the information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.The reported event would be detectable by the clinician and the picc would not be released without chest x-ray confirmation of tip placement.Therefore this event is deemed not reportable per 21 cfr part 803.

Event Description

It was reported by the sales rep that the facility reported having a picc wire that would not display the yellow 3cg rhythm.They stated the rhythm line was either flat-line or squared off artifact.They also stated that sometimes the rhythm would show up of they held the picc wire at just the right spot or manipulated it.The sales rep stated that chest x-rays were used to verify tip location.There was no reported patient injury.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY
• 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: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 7179462
• MDR Text Key: 96967521
• Report Number: 3006260740-2017-02388
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034558
• UDI-Public: (01)00801741034558
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 1275108D
• Device Catalogue Number: 1275108D
• Device Lot Number: REBX2497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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