MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported length of midline catheter sheared off during insertion, requiring or to remove form vein.Here is one for a broken midline that required surgery to remove the piece that broke off.Additional information 06/05/2024: it was reported the adverse event that the patient experienced was having to go to the or to have the retained length of catheter removed from her arm.This was a surgery that she otherwise would not have needed.She tolerated the surgery well and i do not know of any other complications.The iv therapy nurse was attempting to place the midline when they encountered resistance.They tried to remove the catheter from the patient but when they pulled it out, they noticed that a part of the catheter was still in the patient.The md was notified and the patient had an x-ray done that showed the piece of the catheter in the patient¿s vein.Surgery was emergently ordered and the patient was in the or soon after that.The catheter piece wasn't in her arm for more than a couple hours at most.Additional information provided 06/19/2024: patient was admitted starting (b)(6) 2024.
Additional 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 manufacturer has received the sample and will evaluate.Results are expected soon.
Additional 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 complaint of a break in the catheter was confirmed.The product returned for evaluation was two 10 cm catheters from 20 ga powerglide pro devices.The investigation findings are consistent with catheter damage caused by contact with a sharp-edged instrument such as a needle.The returned product sample was evaluated and a break in the catheter was observed towards the distal end of the catheter of sample 1.Observations of sample 2 revealed nothing remarkable along the length of the catheter.No use residues were observed along sample 2.Microscopic examination of the catheter break of sample 1 confirmed it was typical of contact with a needle, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on the bevel of a needle.The fracture edges were sharply formed and had planar (flat) surfaces.The damage also contained the overall shape of a chevron 'v'.This shape is common to many needle bevels, and this shape is often transferred onto the catheter when punctured by a needle.It appeared likely that the catheter was damaged by contact with the integrated introducer needle during device insertion.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported length of midline catheter sheared off during insertion, requiring operating room to remove form vein.Here is one for a broken midline that required surgery to remove the piece that broke off.Additional information 06/05/2024: it was reported the adverse event that the patient experienced was having to go to the operating room to have the retained length of catheter removed from her arm.This was a surgery that she otherwise would not have needed.She tolerated the surgery well and i do not know of any other complications.The iv therapy nurse was attempting to place the midline when they encountered resistance.They tried to remove the catheter from the patient but when they pulled it out, they noticed that a part of the catheter was still in the patient.The md was notified and the patient had an x-ray done that showed the piece of the catheter in the patient¿s vein.Surgery was emergently ordered and the patient was in the operating room soon after that.The catheter piece wasn¿t in her arm for more than a couple hours at most.Additional information provided 06/19/2024: patient was admitted starting (b)(6) 2024.

• Brand Name: FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19595085
• Report Number: 3006260740-2024-03227
• Device Sequence Number: 3980430
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F320108PT
• Device Lot Number: REJN3798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female