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

Model Number	1718500
Medical Device Problem Codes	Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approximately three years and eleven months post port placement procedure, the port was allegedly unable to be flushed.It was further reported that the catheter was allegedly broken.Reportedly, had procedure to remove the port and only two portions of the catheter.Snare was used to remove floating/dislocated portion of the catheter.There was no reported patient 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 device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 08/2021).
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 powerport ti l/p implantable port attached to a groshong catheter in two segments were returned for evaluation and two electronic photos were provided for review.The investigation is confirmed for the reported fracture, material separation and identified deformation and wear issues as a complete circumferential break was noted on the returned catheter.The edges of the complete circumferential break was noted to be rounded in one region and granular in another.The surface was noted to be granular and glossy.Further a partial compound break was noted at the proximal end of the distal catheter segment.The edges of the partial compound break on the distal catheter segment was noted to be jagged.The surface was noted to be round in one region and granular in another region.However, the investigation is inconclusive for the reported difficult to flush issue as the exact circumstances at the time of the reported event cannot be verified.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.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: 08/2021), g3, h6 (device, method).H11: h6 (result, 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 approximately three years eleven months post port placement procedure, the port was allegedly unable to be flushed.It was further reported that the catheter was allegedly broken.Reportedly, had procedure to remove the port and only two portions of the catheter.Snare used to remove floating/dislocated portion of the catheter.There was no reported patient injury.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 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: 14403818
• Report Number: 3006260740-2022-01806
• Device Sequence Number: 17544524
• Product Code: LJT
• UDI-Device Identifier: 00801741026812
• UDI-Public: (01)00801741026812
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 1718500
• Device Catalogue Number: 1718500
• Device Lot Number: REBQ0194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/15/2022
• Supplement Report FDA Received Date: 06/10/2022
• 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
• Patient Sex: Unknown