MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0603840
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.
Event or Problem Description
It was reported that post device implant, the device allegedly leaked drug from the diaphragm.It was further reported that the patient experienced redness and swelling due to the leak.The port was removed and the procedure was completed using another device.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one hard base port attached to a catheter was returned for evaluation.Visual, microscopic visual and functional evaluation were returned for evaluation.A circumferential break was noted on the catheter just distal to the cath-lock.Striations were noted on the circumferential break surface.Further during functional evaluation, the port body with attached catheter segment was patent to infusion and aspiration without issue.However, the investigation is inconclusive for the reported fluid leak issue as the exact circumstances at the time of the reported event are unknown and the clinical conditions alleged in the complaint cannot be confirmed.A definitive root cause could not be determined.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: g3.H11: h6 (method, result and conclusion).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 or Problem Description
It was reported that post device implant, the device allegedly leaked drug from the diaphragm.It was further reported that the patient experienced redness and swelling due to the leak.The port was removed and the procedure was completed using another device.The current status of the patient is unknown.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
• 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
• MDR Report Key: 11184397
• Report Number: 3006260740-2020-21368
• Device Sequence Number: 3433415
• Product Code: LJT
• UDI-Device Identifier: 00801741025822
• UDI-Public: (01)00801741025822
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 0603840
• Device Catalogue Number: 0603840
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other