MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8806060

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/30/2022

Event Type  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.(expiration date: 08/2023).

Event Description

It was reported that approximately five months post port placement, the port allegedly migrated cephalad into the jugular vein.The current status of the patient is unknown.

Event Description

It was reported that approximately five months post port placement, the port allegedly migrated cephalad into the jugular vein.The current status of the patient is unknown.

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 mri implantable port attached to a catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed on the returned device.A complete circumferential break was noted on the distal end of the attached catheter and the edges of the complete circumferential break were noted to be uneven.The surface was noted to be granular with residue throughout.The investigation is inconclusive for the reported migration issue as the exact circumstances at the time of the reported event is unknown.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: 08/2023).H11: section a through f ¿ the information provided 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.

• Brand Name: POWERPORT ISP MRI 6CF INT W SP, ATT, SL
• 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: 16245227
• MDR Text Key: 308144735
• Report Number: 3006260740-2023-00129
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098956
• UDI-Public: (01)00801741098956
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8806060
• Device Lot Number: REGN2595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• 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
• Patient Outcome(s): Required Intervention