MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F NURSE BASIC TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 3194118

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

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

Event Date 03/27/2018

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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reby0147 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby0147) have been reported from the same (b)(6) facility.

Event Description

It was reported that the picc was inserted (b)(6) 2018.On (b)(6) 2018, the nurse was infusing medication and the pump began alarming that there was an occlusion.Upon assessment the nurse was unable to flush picc and found that it was fully occluded.¿picc 50 cm and external length = 9 cm.¿ a vascular access nurse saw the patient in the morning of (b)(6) 2018 for the occlusion.A chest x-ray showed that the picc tip migrated, but there was no change in external length.The picc was removed and a kink was noted at the 18cm mark (that would be inside of the patient.) 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 catheter kink, which contributed towards an occlusion, was confirmed and was determined to be use related.The product returned for evaluation was a 4fr s/l powerpicc solo catheter.The sample contained blood and usage residue throughout and a permanent kink impression in the catheter shaft was observed between the 20cm -21cm depth markings.The catheter tubing was microscopically examined in, and around, the kink region and no potential tubing defect or deficiency was observed.A segment of catheter tubing was taken near the 21cm depth marking and measured for dimensional conformity.The inside and outside diameters were measured to be within specification.The kink impression appeared to have occurred during use and can be mitigated by placing the catheter in regions which are not prone to kinking.A lot history review (lhr) of reby0147 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby0147) have been reported from the same (b)(6) facility.

Event Description

It was reported that the picc was inserted (b)(6) 2018.On (b)(6) 2018, the nurse was infusing medication and the pump began alarming that there was an occlusion.Upon assessment the nurse was unable to flush picc and found that it was fully occluded.¿picc 50 cm and external length = 9 cm.¿ a vascular access nurse saw the patient in the morning of (b)(6), 2018 for the occlusion.A chest x-ray showed that the picc tip migrated, but there was no change in external length.The picc was removed and a kink was noted at the 18cm mark (that would be inside of the patient.) no patient injury reported.

• Brand Name: POWERPICC SOLO CATHETER 4F NURSE BASIC TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7470514
• MDR Text Key: 106865541
• Report Number: 3006260740-2018-00854
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027741
• UDI-Public: (01)00801741027741
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3194118
• Device Catalogue Number: 3194118
• Device Lot Number: REBY0147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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