MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER FULL KIT (4F) (DUAL-LUMEN) (20CM)

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/03/2024

Event Type  Injury  

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 will evaluate.Results are expected soon.

Event Description

It was reported, "concerned that the 'warning flags' contain a different warning on each side." additional information received 09 february 2024: the concern regarding the stylet warning tag originated from an event.The stylet was believed to have accidentally been cut.Subsequent x-ray imaging confirmed the presence of a wire-like fragment within the patient.

Event Description

It was reported, "concerned that the 'warning flags' contain a different warning on each side." additional information received 09 february 2024: the concern regarding the stylet warning tag originated from an event.The stylet was believed to have accidentally been cut.Subsequent x-ray imaging confirmed the presence of a wire-like fragment within the patient.

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 cut stylet was determined to be inconclusive.Two photographs of a warning tag on a stylet were returned for evaluation.An initial visual observation of the photographs showed both sides of the warning tag on the stylet.No use residue was observed on the sample in the returned photographs.A cut stylet was not observed in the returned photographs.No evidence was submitted which would suggest that the product did not perform as intended after following the procedures outlined within the product instructions for use.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: BARD POWERMIDLINE CATHETER FULL KIT (4F) (DUAL-LUMEN) (20CM)
• Type of Device: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18826780
• MDR Text Key: 336852786
• Report Number: 3006260740-2024-00890
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P6254208
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention