MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redu0643 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

Event Description

It was reported that "the 3 fr midline frayed when advancing through the skin and was extremely difficult to enter the vessel." additional information: " one half of the peel-away sheath is completely frayed.I would like to send this in for evaluation.Ever since the clinical educator recommended not nicking the skin for insertions when possible, i have been able to shy away from this practice on roughly 85% of my line insertions; picc and midline alike.The 3 fr midline, theoretically, should be least likely to require a skin nick.The one i have saved frayed when advancing through the skin and was extremely difficult to enter the vessel.After peeling away i can clearly see why i had such trouble.".

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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer sheath is confirmed; however, the exact cause is unknown.One 3.5 fr 7 cm microintroducer sheath and dilator were returned for evaluation.An initial visual observation showed use residue on the returned sample.The introducer sheath was returned split in half, and the length of the dilator was observed to be slightly curved.The distal tip of the introducer sheath was observed to be damaged.A microscopic observation revealed one edge of the tip of the introducer sheath was folded inward, forming a point and plastically deformed at the corners of this fold.No damage was observed on the distal tip of the dilator.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.A lot history review (lhr) of redu0643 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

Event Description

It was reported that "the 3 fr midline frayed when advancing through the skin and was extremely difficult to enter the vessel." additional information: " one half of the peel-away sheath is completely frayed.I would like to send this in for evaluation.Ever since the clinical educator recommended not knicking the skin for insertions when possible, i have been able to shy away from this practice on roughly 85% of my line insertions; picc and midline alike.The 3 fr midline, theoretically, should be least likely to require a skin knick.The one i have saved frayed when advancing through the skin and was extremely difficult to enter the vessel.After peeling away i can clearly see why i had such trouble.".

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9700446
• MDR Text Key: 194137415
• Report Number: 3006260740-2020-00481
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: S4153108D
• Device Lot Number: REDU0643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1