MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0602833
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2023).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 pending return.
Event or Problem Description
It was reported that sometimes post a port placement, the device allegedly had a subcutaneous leakage during drug administration.There was no reported patient injury.
Event or Problem Description
It was reported that sometimes post a port placement, the device allegedly had a subcutaneous leakage during drug administration.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one bardport implantable port and a groshong catheter was received for evaluation.The cath-lock was received detached.Visual, microscopic, tactile and functional evaluations were performed.Upon infusion, no leaks were observed.Multiple splits were noted to the proximal end portion of the catheter.Therefore, the investigation is unconfirmed for the reported leak issue and confirmed for identified fracture.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 04/2023), g3, h6 (device).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.

• Brand Name: M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F
• Common Device Name: 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: 18226059
• Report Number: 3006260740-2023-05395
• Device Sequence Number: 6222213
• Product Code: LJT
• UDI-Device Identifier: 00801741025723
• UDI-Public: (01)00801741025723
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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 Catalogue Number: 0602833
• Device Lot Number: REET2746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown