MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6FR TL PP SOLO MB KIT; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	1396108D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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) of reaz0049 showed one other similar product complaints from this lot number.
Event or Problem Description
Sales rep reported that there is an alleged crack in the hub of 6 fr triple lumen catheter.No patient injury was reported.
Additional 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 crack in the white connector was confirmed, and was considered manufacturing related.The implicated and returned product was a 6fr triple-lumen powerpicc solo.Three non-bas injection caps were received with the catheter.The t/l tubing extended 26.0cm from the distal end of the trifurcation.A 1cm longitudinal crack was observed in the white connector.The crack was located approximately 1mm to the side of the parting line opposite from the gate.The cavity id was ¿o¿.No other cracks were observed on the white connector or on any other connector.A microscopic examination revealed that the crack had sharp edges and no plastic deformation was observed.A functional test revealed that fluid would leak from the crack during infusion.The complaint sample was forwarded to the manufacturing facility for further review.(b)(4) evaluation: the complaint for ¿valve cracked¿ is confirmed according the evaluation the sample received which showed a microscopic evaluation showed an break in the molding valve , maybe those are caused by the incorrect molding process, leading to valve breakage., maybe these are caused by the incorrect molding process, leading to valve breakage.This condition cause leak in the device.Therefore the cause for this complaint is manufacturing related.The re-event was opened for the tracking of this issue.A lot history review (lhr) of reaz0049 showed one other similar product complaints from this lot number.
Event or Problem Description
Sales rep reported that there is an alleged crack in the hub of 6 fr triple lumen catheter.No patient injury was reported.

• Brand Name: 6FR TL PP SOLO MB KIT
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6802489
• Report Number: 3006260740-2017-01335
• Device Sequence Number: 1077937
• Product Code: LJS
• UDI-Device Identifier: 00801741034749
• UDI-Public: (01)00801741034749
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 1396108D
• Device Catalogue Number: 1396108D
• Device Lot Number: REAZ0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1