MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT,4FR POWERMIDLINE; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "after placing a bard traditional powermidline catheter and upon removing the stylet/wire, i noticed the wire seemed very long and fragile/flimsy in appearance.I put the equipment aside and completed the midline insertion by flushing and checking blood return.After successfully completing mid insertion, i examined the wire and it appeared frayed and fractured.".
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation.Device not returned for evaluation.
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.Based on a review of this information, the following was concluded: the complaint of a frayed and fractured stylet is confirmed and was determined to be use related.One t-lock assembly with the stylet inside was returned for evaluation.A microscopic observation revealed the distal welded tip of the stylet to be missing.The fracture surface of the core wire appeared granular and appeared to be broken at an angle.The observed characteristics of the break sites in the returned stylet are indicative of damage caused by a sharp instrument such as scissors.Due to the angle of the break in the core wire and the fracture surface of the break in the core wire, the complaint of a broken stylet is confirmed and was determined to be cut.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer "after placing a bard traditional powermidline catheter and upon removing the stylet/wire, i noticed the wire seemed very long and fragile/flimsy in appearance.I put the equipment aside and completed the midline insertion by flushing and checking blood return.After successfully completing mid insertion, i examined the wire and it appeared frayed and fractured.".

• Brand Name: DOT,4FR 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16941104
• Report Number: 3006260740-2023-01925
• Device Sequence Number: 15255391
• Product Code: PND
• UDI-Device Identifier: 00801741108754
• UDI-Public: (01)00801741108754
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: P4154108
• Device Lot Number: REGV3341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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