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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3006260740-2022-05961
• Device Sequence Number: 16655411
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 73 KG