MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; MIDLINE CATHETER

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redr2840 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "during use, the peel away sheath did not peel evenly and did not peel all the way down." on (b)(6) 2020: it was stated this happened during a classroom training with no patient involvement.

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) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an improper peel is confirmed but the exact cause could not be determined from the photo sample provided.Two photo samples of a grey peel apart microez microintroducer were provided for evaluation.The first photo shows the product label sticker and a peeled microintroducer.One side of the sheath is significantly curled and appears to be stretched.The other side of the peel apart sheath appeared to be unevenly peeled at the distal end.The second photo shows the peel apart sheath which was not curled.The distal end of the sheath did not evenly peeled.Since a peel issue was observed, the complaint is confirmed; however, the exact cause could not be determined from the characteristics visible in the photos.A lot history review (lhr) of redr2840 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "during use, the peel away sheath did not peel evenly and did not peel all the way down." 2/17/ 20- it was stated this happened during a classroom training with no patient involvement.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9787821
• MDR Text Key: 194128209
• Report Number: 3006260740-2020-00715
• 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
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REDR2840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1