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

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The complaint of stylet coating material bunching along the device is confirmed and was determined to be related to manufacturing.Six unopened 4 fr s/l power midline kits and seven stylets were returned for evaluation.All the returned stylets were from the same lot, rejp0623.Microscopic inspection of each of the six stylets from the unopened power midline kits showed early delamination of the stylet coating noted by white sections observed along each of the six stylets before use or exposure of the products to outside elements.The complaint of an unknown substance found along the stylet is confirmed and was determined to be related to the manufacture of the product.An initial visual observation of five of the seven returned, opened stylets revealed use residues throughout the stylets along the returned device.A photo sample showing two opened, used stylets was also returned for investigation matching two of the returned samples.It was observed that white stylet coating material was observed along each of the five devices.A tactile evaluation each stylet revealed an uneven surface along the devices where it was observed that coating material bunched.Significant delamination of the stylet coating was observed for each device.The complaint of an unknown substance found along the stylets is confirmed and was determined to be related to the manufacture of the product.Because there were 12 additionally alleged lot samples in the parent record, one of the alleged samples was not returned, and is therefore a no sample file.Because this alleged device was not returned for evaluation, the complaint of white coating material along the stylet is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, 12 stylets to have multiple micro razed areas this report addresses all twelve devices.

• Brand Name: POWERMIDLINE
• 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: 22734407
• Report Number: 3006260740-2025-05607
• Device Sequence Number: 7198729
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761(11)240319(17)250731(10)REJP0623
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/06/2025

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REJP0623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/06/2025
• 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: Other
• Patient Sex: Unknown