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

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that when removing introducer needle from patient and engaging the safety, the green safety portion came apart from the needle.Vein size recorded as 0.28.Midline catheter inserted via modified seldinger technique right basilic and secured at 10cm.There were no injuries with this incident.No other information was provided.
Event or Problem Description
Additional information received via medwatch: it was reported nurse removed the remaining portion of the needle manually.
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.
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 needle detachment was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was two 21ga secureloc safety introducer needles.Use residues were observed in both samples.Inspection of the first sample (sample 1) revealed that the needle shaft was completely detached from the luer adapter.The safety mechanism was detached from the needle shaft.No plastic deformation was observed at the needle shaft bore.What appeared to be adhesive as observed within the luer adapter bore, near the distal end.No adhesive residue was observed on the needle shaft.Microscopic inspection of the safety mechanism was unremarkable.Microscopic inspection of sample 1 confirmed that the needle shaft was fully detached from the plastic luer adapter.The position of the adhesive within the luer bore suggested that the needle was not fully inserted into the bore during the luer bonding process.This likely caused the needle shaft to become detached.Inspection of the second sample (sample 2) was unremarkable.The sample was received with an adhesive note attached to the needle which labeled the needle as ¿normal¿.Microscopic inspection of sample 2 was unremarkable.It appeared that the second sample was provided as a comparative example.

• Brand Name: PROVENA 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: 21941823
• Report Number: 3006260740-2025-02743
• Device Sequence Number: 9121502
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952(11)250317(17)260731(10)REKP0118
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2025

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: S4153108D
• Device Lot Number: REKP0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 07/03/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/13/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White