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); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2023).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.
Event or Problem Description
It was reported that sometime post a port placement, the patient allegedly complained of pain when administering the drug and the catheter was allegedly found to be torn and floated on central vein under fluoroscopy examination.It was further reported that during infusion, the saline allegedly leaked.Furthermore, the patient did not underwent any medical intervention nor medications prescribed to treat pain.Reportedly, the floated part of the catheter has been retrieved.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one bardport mri implantable port attached to a groshong catheter in two segments was received for evaluation.Microscopic visual, gross, tactile and functional testing were performed.A complete circumferential break was noted on the distal end of the attached catheter that was elliptical in shape.A complete circumferential break was noted on the proximal end of the distal catheter segment that was elliptical in shape.A compound break was noted approximately 0.9cm from the proximal end of the distal catheter segment.The edges of the complete circumferential break on the distal end of the attached catheter were noted to be uneven.The surface was noted to be granular with residue throughout.The edges of the complete circumferential break on the proximal end of the distal catheter segment were noted to be uneven.The surface was noted to be granular with residue throughout.The edges of the compound break were noted to be uneven.The surface was noted to be round and smooth in both regions.Splits were noted on the border of both regions.Upon infusion, a leak from the compound break was observed.Therefore, the investigation is confirmed for the reported fracture, material separation, fluid leak and migration and identified wear, deformation issues.However, the investigation is inconclusive for the reported migration as the exact circumstances at the time of the reported event is unknown.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.Such kinking may have physiological, placement, usage or mechanical contributing factors.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6(device, method).H11: h6(result, conclusion).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.
Event or Problem Description
It was reported that sometime post a port placement, the patient allegedly complained of pain when administering the drug and the catheter was allegedly found to be torn and floated on central vein under fluoroscopy examination.It was further reported that during infusion, the saline allegedly leaked.Furthermore, the patient did not underwent any medical intervention nor medications prescribed to treat pain.Reportedly, the floated part of the catheter has been retrieved.The current status of the patient is unknown.

• 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: 19564806
• Report Number: 3006260740-2024-03124
• Device Sequence Number: 6974333
• 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): 08/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 0602833
• Device Lot Number: REEN1471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• 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: Required Intervention
• Patient Sex: Unknown