MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
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 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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that the safety did not deploy and the green safety did not stay on the 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 detached safety mechanism is confirmed; however, the exact cause is unknown.One photograph of an introducer needle was returned for evaluation.An initial visual observation of the photograph showed an introducer needle with the safety barrel completely separated from the needle shaft inside a plastic bag.Evidence of use was observed on the sample in the returned photograph.Although a complete detachment of the safety barrel was observed, there were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: DOT 3FR SL PROV ML
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21226107
• Report Number: 3006260740-2025-00118
• Device Sequence Number: 12648409
• Product Code: PND
• UDI-Device Identifier: 00801741185052
• UDI-Public: (01)00801741185052(11)241010(17)251031(10)REJU3523
• 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): 03/14/2025

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: SP4153108D
• Device Lot Number: REJU3523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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