MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0607550

Device Problems Fracture (1260); Material Separation (1562); Insufficient Information (3190); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Pneumothorax (2012); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2014

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported fracture, material separation and migration as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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.H3 other text: device not returned.

Event Description

It was reported through litigation process that sometime post a port placement, the catheter allegedly fractured and migrated to the heart.It was further reported that patient allegedly developed blood clots, pulmonary embolism and experienced lung puncture.However, the current status of the patient is unknown.

Manufacturer Narrative

H10: additional information was received and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a serious injury.H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.

Event Description

It was reported through litigation process that post a port placement procedure, there was no device malfunction reported and patient did not experienced any adverse event.There was no reported patient injury.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18569670
• MDR Text Key: 333551548
• Report Number: 3006260740-2024-00163
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026195
• UDI-Public: (01)00801741026195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0607550
• Device Lot Number: REXI0821
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MULTI-VITAMIN AND VITAMIN B12; XANAX, VITAMIN D
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Race: White