MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 DOT,4FR POWERMIDLINE; MIDLINE CATHETER

Model Number N/A

Device Problems Material Frayed (1262); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redn2797 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the vat nurse was pulling the internal wire out to trim, met with resistance and a piece of the wire sheared off.On (b)(6) 2019: it was reported that the line was not placed in patient.The nurse pulled the internal catheter wire out of midline, a piece of the wire frayed off inside the rubber stopper that it passes through.No patient harm reported as the device was not used on a patient.

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 of a damaged stylet wire was confirmed, and it appeared that the wire was inadvertently cut.One stiffening stylet was returned for investigation.The stylet wire was received without the t-lock extension set.The distal end of the coil wire was extending beyond the distal tip of the core wire.A microscopic examination revealed that the weld tip was not present at the distal tip of the stylet wire.The distal tip of the core wire exhibited regions of increased luster, which indicates that the wire was sheared with a sharp instrument.The core wire extended 41.1cm from the distal end of the black tab, which indicates that 0.4 to 1.4 cm of the stylet wire was missing.When modifying the catheter length, the ifu states, ¿retract the stylet to well behind the point the catheter is to be cut.Using a sterile scalpel or scissors, carefully cut the catheter according to institutional policy, if necessary.Caution: the stylet or stiffening wire needs to be well behind the point the catheter is to be cut.Never cut the stylet or stiffening wire.¿ the ifu also indicates that the t-lock extension set and stylet wire should be removed as a unit.

Event Description

It was reported the vat nurse was pulling the internal wire out to trim, met with resistance and a piece of the wire sheared off.5/20/19 - additional information received: it was reported that the line was not placed in patient.The nurse pulled the internal catheter wire out of midline, a piece of the wire frayed off inside the rubber stopper that it passes through.No patient harm reported as the device was not used on a patient.

• Brand Name: DOT,4FR POWERMIDLINE
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• MDR Report Key: 8679207
• MDR Text Key: 147454538
• Report Number: 3006260740-2019-01589
• 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: 06/13/2019

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 Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REDN2797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Event Location: Hospital
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1