MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,4FR POWERMIDLINE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 01/05/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx2330 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the powermidline was leaking at the hub at insertion when they flushed the catheter.

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 leak is confirmed and was determined to be manufacturing related.One 4 fr single lumen power midline was returned for evaluation.An initial visual observation showed use residue throughout the returned sample.A large split was observed between the extension leg tubing and the molded joint.A microscopic observation revealed the extension leg tubing to be partially detached from the molded joint.The extension leg tubing was observed to not be torn or broken.Only about a millimeter of the extension leg tubing was observed to be within the proximal end of the molded joint.Striations were observed on the detached end of the extension leg tubing suggesting it is the manufactured end.The striations on the end of the extension leg tubing were observed to be mirrored on the surface of the molded joint at the break site.A lot history review (lhr) of recx2330 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the powermidline was leaking at the hub at insertion when they flushed the catheter.

• Brand Name: DOT,4FR POWERMIDLINE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8340906
• MDR Text Key: 136504438
• Report Number: 3006260740-2019-00262
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: RECX2330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1