MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT POWER MIDLINE; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Defective Component (2292)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported, ¿this guide wire did not look this way until after i tried to put it in the pt., at which time i could not advance it and literally had to force it out of the vein! the vein was no longer usable after that.After i forced the guide wire out, she did have some bleeding and expressed some pain at the site, the bleeding was easily controlled.It did leave a visible hematoma that rapidly appeared, which i normally do not see in my patients, but again she was compromised, and her extremities were covered with bruises.¿ no other information was provided.
Additional 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 complaint of difficult guidewire advancement is confirmed and was determined to be use-related.One 0.018 in.X 50 cm.Nitinol guidewire was returned for evaluation.An initial visual observation revealed abundant blood use residues throughout the returned sample.Slight bends were observed at the distal end of the guidewire.A functional test of attempting to slide a microintroducer over the guidewire revealed the microintroducer would not advance over the distal tip of the guidewire due to the excessive blood residues.A microscopic observation revealed blood use residues and a fibrous substance stuck to the distal end of the guidewire.The complaint of difficulty advancing the guidewire is confirmed and was determined to be caused by excessive blood use residues.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, ¿this guide wire did not look this way until after i tried to put it in the pt., at which time i could not advance it and literally had to force it out of the vein! the vein was no longer usable after that.After i forced the guide wire out, she did have some bleeding and expressed some pain at the site, the bleeding was easily controlled.It did leave a visible hematoma that rapidly appeared, which i normally do not see in my patients, but again she was compromised, and her extremities were covered with bruises.¿ no other information was provided.

• Brand Name: DOT POWER MIDLINE
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19338029
• Report Number: 3006260740-2024-02406
• Device Sequence Number: 8739899
• Product Code: PND
• UDI-Device Identifier: 00801741138478
• UDI-Public: (01)00801741138478
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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): 07/03/2024

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 Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000727
• Device Lot Number: REHY2535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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 Sex: Unknown