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

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported the us (ultra sound) gel was leaking though the sterile probe cover that came with the kit.
Additional 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 or Problem 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
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9682558
• Report Number: 3006260740-2020-00439
• Device Sequence Number: 2800779
• Product Code: PND
• UDI-Device Identifier: 00801741144837
• UDI-Public: (01)00801741144837
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1