MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607530
Medical Device Problem Codes	Failure to Infuse (2340); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
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.The investigation of the reported event is currently underway.Expiry date (07/2022).
Event or Problem Description
It was reported that approximately one month post implant the port system was allegedly failed to infuse.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: one x-port with a catheter in two segments was returned for evaluation.Functional, gross visual and microscopic visual were performed.A complete circumferential break was noted approximately 1mm from the distal end of the cath-lock.However, striations were noted on both edges of the complete circumferential break and the catheter appeared cut.An in-house syringe was attached to a safety infusion set and the non-coring needle was inserted into the port septum.The port body with attached catheter segment was patent to infusion and aspiration without issue.The investigation is inconclusive for the reported failure to infuse issue, as the exact circumstances at the time of the reported event are unknown.Based on the information available, the 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: d4 expiry date (07/2022), g4.H11: f10(device), h6(method, result, conclusion).H11: section a through f ¿ the information provide 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 : see h10.
Event or Problem Description
It was reported that approximately one month post implant the port system was allegedly failed to infuse.There was no reported patient injury.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 10747333
• Report Number: 3006260740-2020-20273
• Device Sequence Number: 4123106
• Product Code: LJT
• UDI-Device Identifier: 00801741026171
• UDI-Public: (01)00801741026171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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 Model Number: 0607530
• Device Catalogue Number: 0607530
• Device Lot Number: REEQ2758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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