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

Model Number 9808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 01/13/2023

Event Type  malfunction  

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.The investigation of the reported event is currently underway.(expiration date: 09/2024).

Event Description

It was reported that during preparation for a port placement procedure, leakage allegedly occurred while priming before usage.It was further reported that, the leakage may have possibly been occurred from the sheath, but it was also possible that it might have been leaked from the catheter.The procedure was completed using another device.There was no patient contact.

Event Description

It was reported that during preparation for a port placement procedure, leakage allegedly occurred while priming before usage.It was further reported that, the leakage may have possibly been occurred from the sheath, but it was also possible that it might have been leaked from the catheter.The procedure was completed using another device.There was no patient contact.

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 mri implantable port kit.Following components were received: one powerport implantable port, one introducer needle, one 8.0fr peel-apart sheath and vessel dilator, one vein pick, one right-angle and one straight non-coring needle, one flushing connector attached to a groshong catheter with a loaded cath-lock, one j-tip guidewire loaded in a guidewire hoop, one tunneler and one unsealed safety infusion set were returned for evaluation.Gross visual, microscopic visual, tactile and functional evaluations were performed on the returned device.The investigation is confirmed for the identified fracture issue as crack was observed on the introducer needle hub.However the investigation is unconfirmed for the reported fluid leak were observed on the port septum, catheter and peel-apart sheath.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: 09/2024), g3, h6 (method).H11: h6 (result, conclusion).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.H3 other text : see h10.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 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: 16331505
• MDR Text Key: 309196799
• Report Number: 3006260740-2023-00385
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: REGT1321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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