MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F NURSE FULL TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Knotted (1340)

Patient Problem Pain (1994)

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) review is not possible; the manufacturing lot number that was provided is incorrect.

Event Description

The facility reported that they had a picc that "tied itself in a knot." they also reported that there was no harm to the patient, but the patient did feel pain upon removal of the device.

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 knot in the picc was confirmed, and it appeared that the picc was damaged during use.One 4fr s/l powerpicc solo was returned for investigation.The catheter was received with the stylet in the lumen.The catheter had been trimmed to length near the 52cm depth mark.An overhand knot was found in the tubing 2.5cm from the distal tip of the picc.Dry blood residue was observed on the catheter near the knot, which indicates that the product was used.The 4.5fr x 7cm introducer sheath was received over the picc tubing proximal to the knot.Since the picc had been advanced through the introducer sheath, the tubing may have inadvertently folded over itself and was twisted into a knot within the vessel.The stylet had been retracted from the section of tubing that was in a knot.The distal tip of the stylet coincided with the 40cm depth mark.Due to the condition of the returned sample, it was determined that the damage occurred during use.A lot history review (lhr) of rebu0386 showed no other similar product complaint(s) from this lot number.

Event Description

The facility reported that they had a picc that "tied itself in a knot." they also reported that there was no harm to the patient, but the patient did feel pain upon removal of the device.

• Brand Name: POWERPICC SOLO CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F NURSE FULL TRAY
• 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: 7154338
• MDR Text Key: 96125364
• Report Number: 3006260740-2017-02327
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 9194108
• Device Lot Number: REBU0386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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