MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; MIDLINE CATHETER

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

T was reported by the customer "the micro introducer sheath accordioned or folded back upon insertion through the skin.Nurse attempted to push pass the skin with minimal success and then tried to pull it out after slightly penetrating the skin and then felt a snug removal.Device was removed successfully with no issue.Additional information received 12/16/2022: it was reported by the healthcare professional ¿i was set up to place the midline.Due to issues, we had been having i thoroughly inspected the introducer before insertion.Everything looked normal.I do not nick before inserting as most insert without issue.I was meeting resistance, so i pulled the introducer back, made a slight nick and reinserted.I did not inspect the introducer before trying the second time, but as it entered the epidermis and then dermis, i was feeling a lot of resistance, like i was going through the back of carpet.I pulled the catheter out and that is when i noticed that the grey part of the introducer had two frays.Another kit (picc kit) was opened, and the introducer used out of that kit with no issues.Device was secured with a statlock.Catheter is still intact due to documentation.No harm but additional pressure/pain during insertion and reinsertion of second introducer.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regp1017 showed four other similar product complaint(s) from this lot number.

• Brand Name: DOT 3FR SL PROV ML
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16088217
• MDR Text Key: 308493538
• Report Number: 3006260740-2022-05961
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/14/2022

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 Model Number: N/A
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REGP1017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 73 KG