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

Model Number 0602820

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Fracture (1260); Peeled/Delaminated (1454)

Patient Problems Extravasation (1842); Pain (1994)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

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.(expiration date: 12/2011).

Event Description

It was reported that approximately fourteen years and ten months post port placement procedure in the left subclavian vein, the contrast medium allegedly leaked.It was further reported that patient experienced pain and extravasation.The current status of the patient is unknown.

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 titanium implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual, tactile and functional evaluation were performed on the returned device.The investigation is confirmed for the identified peeled and degraded issues as the catheter was noted to be degraded from the 15.0cm depth mark to the 16.0cm depth mark and the catheter material appeared to be peeled off in the same region.Further, the investigation is also confirmed for the reported fluid leak and identified fracture issue as a partial c-shaped break was noted to be jagged.During functional evaluation, a leak was noted from the longitudinal split upon infusion.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 12/2011).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.H3 other text : see h10.

Event Description

It was reported that approximately fourteen years and ten months post port placement procedure in the left subclavian vein, the contrast medium allegedly leaked.It was further reported that patient experienced pain and extravasation.The current status of the patient is unknown.

• Brand Name: GROSHONG TITANIUM PORT WITH ATTACHABLE 8F SINGLE-LUMEN
• 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: 14313478
• MDR Text Key: 291204864
• Report Number: 3006260740-2022-01621
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025709
• UDI-Public: (01)00801741025709
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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 Model Number: 0602820
• Device Catalogue Number: 0602820
• Device Lot Number: REQL0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 05/27/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Female