MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2020

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 reeq2429 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the introducer bucked when attempting to insert into patient.A new kit was retrieved, but the introducer was a 4 fr dilator/introducer and caused a larger entry which necessitated additional time to stop any "oozing".It was stated this caused a delay in treatment and an additional poke to the patient with new needle to allow guidewire to pass.

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, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a buckling introducer was confirmed.One 3.5 fr microintroducer was returned for evaluation.The dilator was returned within the sheath.Blood residue was present throughout the device.The pull tabs were had not been peeled.The sheath and dilator shafts were observed to be bend and curved.Microscopic observation of the distal tip of the sheath revealed a section to be deformed.The deformed section was bunched back.The deformation visible on the distal tip and bends in the microintroducer shaft suggest the device experienced resistance during advancement.The product instructions for use (ifu) contains information which may have prevented the resistance contributing to the microintroducer sheath damage.The ifu states, "advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a safety scalpel prior to making incision." a review of the manufacturing records did not reveal evidence to suggest a manufacturing related root cause contributed to the reported event.Since evidence of resistance during advancement and damage to the microintroducer was observed, the complaint is confirmed.A lot history review (lhr) of reeq2429 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the introducer bucked when attempting to insert into patient.A new kit was retrieved, but the introducer was a 4 fr dilator/introducer and caused a larger entry which necessitated additional time to stop any "oozing".It was stated this caused a delay in treatment and an additional poke to the patient with new needle to allow guidewire to pass.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10457580
• MDR Text Key: 204529615
• Report Number: 3006260740-2020-03047
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REEQ2429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 120