MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER BASIC TRAY (6F) (DUAL-LUMEN) (MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 8276118

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2018

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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reax0203 showed no other similar product complaint(s) from this lot number.

Event Description

Prior to use on the patient, a split allegedly occurred when the stylet was pulled.

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 damaged stylet was confirmed and the cause was determined to be use related.One stiffening stylet with t-lock extension set was returned for investigation.The distance between the black tab and the septum on the t-lock extension set was 62 cm.The red hang tag was positioned around the wire between the black tab and the extension set.The core wire is visible through the coiled wire on the proximal side of the extension set.No use residue is observed on the stylet.The implicated 6fr d/l powerpicc was not returned for investigation.A microscopic examination of the stylet revealed that the weld tip was missing from the distal end.Portions of the cross section on both core wire and coil wire exhibited increased luster.A tactile evaluation revealed that the coil wire could be stretched over the core wire.A functional test revealed that the t-lock extension set was patent to infusion and no leaks were observed.The length of the core wire was measured from the distal end of the black tab and was found to be 73.3 cm, which indicates that 2.7 cm- 4.2 cm of the stylet was cut off.The red hang tag on the stylet states ¿warning- do not cut stylet- withdraw stylet before trimming catheter.¿ a lot history review (lhr) of reax0203 showed no other similar product complaint(s) from this lot number.

Event Description

Prior to use on the patient, a split allegedly occurred when the stylet was pulled.

• Brand Name: POWERPICC CATHETER BASIC TRAY (6F) (DUAL-LUMEN) (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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7621167
• MDR Text Key: 112177979
• Report Number: 3006260740-2018-01448
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741140181
• UDI-Public: (01)00801741140181
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K050931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8276118
• Device Lot Number: REAX0203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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