MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 8CF INT. W/SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808060

Device Problems Material Discolored (1170); Fracture (1260)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

It was reported that post port placement procedure, the catheter allegedly had split on its tip.The port was removed and replaced with another port.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the powerport implantable port products that are cleared in the us.The pro code and 510k number for the powerport implantable port products is identified.H10: 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: 02/2023.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.Device pending return.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport implantable port products that are cleared in the us.The pro code and 510k number for the powerport implantable port products is identified in d2 and g4.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 attached to a catheter segment was returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.The investigation is confirmed for the reported catheter fracture and identified discoloration issues as a longitudinal split was noted on the attached catheter approximately 11.7cm from the distal end of the cath-lock.Furthermore, two splits were also noted on the port septum and discoloration was noted throughout the attached catheter.Under microscopic observation, a complete circumferential break was noted on the distal end of the attached catheter and striations was also noted throughout the surface.Upon infusion, a leak with thrombus was observed exiting from the longitudinal split on the attached catheter.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: 02/2023).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 Description

It was reported that post port placement procedure, the catheter allegedly had split on its tip.The port was removed and replaced with another port.There was no reported patient injury.

• Brand Name: POWERPORT ISP MRI 8CF 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: 15359331
• MDR Text Key: 302936699
• Report Number: 3006260740-2022-03476
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098970
• UDI-Public: (01)00801741098970
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/04/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 8808060
• Device Lot Number: REFV0370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 11/14/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Male