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

Model Number 1608062

Device Problems Disconnection (1171); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  malfunction  

Event Description

It was reported that two years nine months post port placement procedure, the port allegedly disconnected from the reservoir.The port was removed from patient.There was no reported patient injury.

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: 11/2020.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport clearvue slim implantable port attached to catheter in two segments were returned for evaluation.Gross, microscopic visual, tactile and functional testing were performed.Therefore, the investigation is inconclusive for the reported disconnection issue as the exact circumstances at the time of the reported event cannot be verified.However, the investigation is confirmed for the identified fracture issue edges of the complete circumferential break on the proximal end of the distal catheter segment were noted to be uneven with surface was noted to be granular and glossy.Also, a piece of catheter was found within the cathlock and edges were noted to be uneven.Furthermore, a complete circumferential break was noted on the distal end of the attached catheter.Under microscopic observation, the edges of the complete circumferential break on the distal end appeared to be uneven and striations were noted throughout.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: d4 (expiry date: 11/2020).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 Description

It was reported that two years nine months post port placement procedure, the port allegedly disconnected from the reservoir.The port was removed from patient.There was no reported patient injury.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX, 8F
• Type of Device: 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: 15705624
• MDR Text Key: 304623384
• Report Number: 3006260740-2022-04202
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026430
• UDI-Public: (01)00801741026430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1608062
• Device Catalogue Number: 1608062
• Device Lot Number: REDV2303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1