MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERMIDLINE CATHETER BASIC KIT (4F) (DUAL-LUMEN) (20CM)

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redv1289 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the midline catheter was frayed.No other information was provided.

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 frayed guidewire is confirmed but the exact cause could not be determined from the photo sample provided.One photo sample of a guidewire was returned for investigation.The distal end of the guidewire was observed to be unraveled.The location at which the coil wire was severed and the presence of the distal weld tip being intact could not be clearly determined.Based on the photo sample provided, possible contributing factors include retraction against resistance and retraction against the needle bevel.Since the guidewire in the photo was observed to be frayed, the complaint is confirmed.The product instructions for use (ifu) cautions, ¿caution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of redv1289 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the midline catheter was frayed.No other information was provided.

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT (4F) (DUAL-LUMEN) (20CM)
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9371333
• MDR Text Key: 168051442
• Report Number: 3006260740-2019-03672
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741141041
• UDI-Public: (01)00801741141041
• Combination Product (y/n): N
• PMA/PMN Number: K162900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: P6254118
• Device Lot Number: REDV1289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1