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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the little piece just broke off and they was stuck with one wing and the whole gray tube around the catheter.No other information was provided.
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 be evaluated.A supplemental will be submitted with evaluation results.
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 an uneven microintroducer sheath split is confirmed and was determined to be related to manufacture of the device.One 4.5 fr microintroducer sheath was returned for evaluation.One photograph of a 4.5 fr microintroducer sheath was returned for evaluation.An initial visual observation of the returned sample revealed blood use residues throughout the device.It was observed that the 4.5 fr side of the orange peel tab was broken from the orange base.It was observed that one side of the gray sheath was broken from the device.A microscopic observation revealed the gray sheath that was broken from the orange tab had an uneven break site.The break site of the gray sheath appeared twisted and narrowed.The fracture surfaces of the break sites of the orange tabs appeared brittle around the outside fracture surfaces.It was observed that one finger tab broke from the orange ring base of the microintroducer tabs.This failure of improper peeling was determined to be related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21141570
• Report Number: 3006260740-2025-00022
• Device Sequence Number: 9236260
• Product Code: PND
• UDI-Device Identifier: 00801741138713
• UDI-Public: (01)00801741138713(11)240719(17)251031(10)REJS3582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000729
• Device Lot Number: REJS3582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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