MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE FULL KIT; MIDLINE CATHETER

Catalog Number	S4153108
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that felt resistance when placing midline and went to retract wire and needle simultaneously.When wire was retracted, they noticed wire was unraveled at the end.Wire was retrieved and patient had to be stuck again.Additional info received on 07-june-23 patient has a history of alcohol abuse and diabetes.No urgent/life threatening situation event discovered when withdrawing the guidewire.The wire did not break but did unravel.No pieces were retained in the patient.A chest, clavicle and arm xray was obtained.Patient did no experience any symptoms, complications or negative outcomes.Additional information received 6/8: wire unraveled approximately 15-20cm from the tip.
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 evaluate.Results are expected soon.
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 damaged guidewire is confirmed; however, the exact cause is unknown.One photograph of a guidewire was returned for evaluation.An initial visual observation of the photograph showed a bag containing a guidewire and a plastic hoop.The guidewire was observed to be unraveled which indicates the core wire was broken.It could not be clearly seen from the returned photograph if the coiled wire was broken.Use residue could be seen on the sample in the returned photograph.No further details of the damage could be discerned in the returned photograph.While the exact cause of the observed damaged guidewire could not be determined from the returned photograph, possible causes include inadvertently advancing guidewire into tissue, withdrawing guidewire over needle bevel, advancing/withdrawing against resistance, and excessive tensile (pulling) force.
Event or Problem Description
It was reported by the customer that felt resistance when placing midline and went to retract wire and needle simultaneously.When wire was retracted, they noticed wire was unraveled at the end.Wire was retrieved and patient had to be stuck again.Additional info received on 07-june-23 : patient has a history of alcohol abuse and diabetes.No urgent/life threatening situation event discovered when withdrawing the guidewire.The wire did not break but did unravel.No pieces were retained in the patient.A chest, clavicle and arm xray was obtained.Patient did no experience any symptoms, complications or negative outcomes.Additional information received 6/8: wire unraveled approximately 15-20cm from the tip.

• Brand Name: 3FR SL PROVENA MIDLINE FULL KIT
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17187496
• Report Number: 3006260740-2023-02581
• Device Sequence Number: 6809327
• Product Code: PND
• UDI-Device Identifier: 00801741153938
• UDI-Public: (01)00801741153938
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/18/2023

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: 05/31/2024
• Device Catalogue Number: S4153108
• Device Lot Number: REGZ2083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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 Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG