MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,4FR POWERMIDLINE; MIDLINE CATHETER

Model Number N/A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of luer adapter detachment from the midline catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a portion of 4fr powermidline midline catheter.The photograph depicted the luer adapter.The adapter was completely detached/broken from the extension tubing, which was not visible in the photograph.It could not be determined from the photograph if the luer was detached from the extension tubing or if the extension tubing had fractured.While catheter damage was clearly evident in the submitted photograph, inspection of that photograph was insufficient to determine the cause of that damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include material fatigue and tensile (pulling) stress.A lot history review (lhr) of redn3945 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the "end broke".No other information provided at this time.

• Brand Name: DOT,4FR POWERMIDLINE
• Type of Device: MIDLINE CATHETER
• 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: 8679210
• MDR Text Key: 147454094
• Report Number: 3006260740-2019-01590
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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: REDN3945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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