MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM TI W 6FR CHRONOFLEX WO SP, INTER. KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1716001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sometime post port placement, the device allegedly had broke.It was further reported that the device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Date of event was entered as date of explant due to system limitations, since date of event was unknown.As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Additional Manufacturer Narrative
H10: date of event was entered as date of explant due to system limitations, since date of event was unknown.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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported failure could not be determined based upon the provided 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(expiry date: 04/2017), g3, h6(method).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 : device not returned.
Event or Problem Description
It was reported that sometime post port placement, the device allegedly had broke.It was further reported that the device was removed and replaced.There was no reported patient injury.

• Brand Name: POWERPORT SLIM TI W 6FR CHRONOFLEX WO SP, INTER. KIT
• 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: 14157980
• Report Number: 3006260740-2022-01361
• Device Sequence Number: 2943694
• Product Code: LJT
• UDI-Device Identifier: 00801741026751
• UDI-Public: (01)00801741026751
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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): 05/24/2022

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: 1716001
• Device Catalogue Number: 1716001
• Device Lot Number: REZD2476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown