MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERMIDLINE CATHETER, 4F SL

Model Number N/A

Device Problem Defective Component (2292)

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 redw2246 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the us (ultra sound) gel was leaking though the sterile probe cover that came with the kit.

Manufacturer Narrative

H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 leaking probe cover was confirmed, but the exact cause could not be determined.One probe cover was returned for investigation.The sample exhibited evidence of use.The probe cover had been unfolded and gel was observed inside the distal end of the probe cover.The probe cover was filled with water, which revealed a weeping leak at the distal folded end of the probe cover 4cm from the tapered sealed corner.A microscopic examination of the leak site revealed a hole that was smaller than a 0.5mm x 0.5mm area.Scuff marks were observed on the probe cover around the leak site.The edge of the hole exhibited plastic deformation, which indicates that the material may have been stretched before it was breached.The thickness of the probe cover was found to be within specification.Due to the condition of the sample, it is possible that the probe cover was damaged during use; however, the exact mechanism of damage could not be determined.A lot history review (lhr) of redw2246 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the us (ultra sound) gel was leaking though the sterile probe cover that came with the kit.

• Brand Name: POWERMIDLINE CATHETER, 4F SL
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9682558
• MDR Text Key: 188743708
• Report Number: 3006260740-2020-00439
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741144837
• UDI-Public: (01)00801741144837
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: CK000799A
• Device Lot Number: REDW2246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1