MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MIDLINES, POLYURETHANE, ACCUCATH ACE, N/A; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, when we took the accucath out of the package it was bent to the left and when the safety was hit the needle didn't retract and it stayed outside.It did not impact the patient.She opened the packaging and got everything set up.When she popped off the cap to the accucath it looked off to me.She restarted and opened another accucath kit instead.06/10/2025: the returned device exhibited a bent needle.
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 bent needle was confirmed but the cause is unknown.A single photograph of a 20g accucath ace intravascular catheter system housing was returned for evaluation.The catheter had been deployed off of the housing, but the needle had not been retracted.The needle cannula was bent where it exited the housing.It is likely that the bend in the needle prevented proper needle retraction as reported by the customer.The exact cause of the bend in the needle is unknown.It is possible for the needle to become bent due to rough shipping/storage conditions or during device use.The device is packaged with a protective guard over the needle which should reduce the occurrence of bent needles due to shipping/storage.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: MIDLINES, POLYURETHANE, ACCUCATH ACE, N/A
• 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: 22352657
• Report Number: 3006260740-2025-04366
• Device Sequence Number: 15608658
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010(11)250208(17)260430(10)REJZ1181
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• 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): 06/16/2025

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: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REJZ1181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2025
• 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