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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the extension legs detached from the powermidline was confirmed and the cause appeared to be manufacturing related.Two 4fr single-lumen (s/l) powermidline catheters were returned for investigation.The catheters exhibited evidence of use.Non-vad injection caps were attached to the connectors.Each extension leg separated from the molded wing.No portion of the extension leg was observed within the molded wing.The molded insertion depth of the extension leg within the wing appeared to be insufficient.It appears that each extension leg detached from the molded wing due to the shallow insertion depth.The manufacturing facility was notified of this complaint.Complaint due to ¿purple extension leg detached¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual, and measurements taken at vad lab it was concluded that the insertion depth of the purple extension tube on mold pin used during the molding process was not enough causing the reported event.Therefore, the cause of this condition is manufacturing related.As part of reinforcement about this issue, an awareness communication was provided to all personnel involved on this operation.A lot history review (lhr) of reds2452 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that the facility had an issue with two power midlines.Further information has been requested.2/5/2020 - returned catheter shows detached extension legs.This report addresses the first device.

• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 9733328
• MDR Text Key: 198165447
• Report Number: 3006260740-2020-00588
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REDS2452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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