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

Model Number	0602810
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional 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.However, a photo and a video were provided for review.The investigation of the reported event is currently underway.Expiration date: 10/2023.Device pending return.
Event or Problem Description
It was reported that approximately thirty one days post port placement procedure, the port catheter allegedly leaked at the suture line.It was further reported that the suture site showed signs of infection and the infection was treated.Reportedly the port catheter was removed.The patient reported to be stable.
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 titanium implantable port attached to a groshong catheter with a loaded unknown guidewire on the distal end were returned for evaluation.Gross, microscopic visual, functional testing and tactile evaluation were performed.In addition to the returned physical sample, one electronic video and photo were provided for review.The investigation is confirmed for the reported fluid leak issue as a split was noted on the catheter approximately 1.9cm from the distal end of the cath-lock.Upon infusion, a leak from the split on the catheter was observed while water exited the distal end.The video review also confirms the same.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.A definitive root cause could not be determined based upon the 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: b2, b5, d4 (expiration date: 10/2023).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.
Event or Problem Description
It was reported that approximately thirty one days post port placement procedure, the port catheter allegedly leaked at the suture line.It was further reported that the suture site showed signs of infection and swelling occurred in the right infraclavicular region.Reportedly, the infection was treated and the port catheter was removed.The patient reported to be stable.

• Brand Name: TITANIUM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN VENOUS CATHETER, 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: 14394990
• Report Number: 3006260740-2022-01768
• Device Sequence Number: 5989964
• Product Code: LJT
• UDI-Device Identifier: 00801741025693
• UDI-Public: (01)00801741025693
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: 0602810
• Device Catalogue Number: 0602810
• Device Lot Number: REDS3755
• 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: 04/18/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 07/04/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 62 KG