MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8806061

Device Problems Component Missing (2306); Component Misassembled (4004)

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

Event Date 01/19/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of a port placement procedure on right internal jugular vein, the syringe introducer needle was allegedly missing upon opening the package.It was further reported that additional non-coring needle was instead of it.There was no patient contact.

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 in common device name and date rec'd by mfr.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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2023).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: 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 isp mri port, one catheter, one cath-lock, one syringe, one j-tip guidewire loaded in a guidewire hoop, one tunneler, one 6.5fr introducer peel-apart sheath and vessel dilator were returned for evaluation.Gross visual evaluations was performed.Although sample was returned for evaluation, two electronic photos were provided for review.However, the investigation is inconclusive for the reported component missing issue as the exact circumstances at the time of the reported event are unknown.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: 01/2023).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 during preparation of a port placement procedure on right internal jugular vein, the syringe introducer needle was allegedly missing upon opening the package.It was further reported that additional non-coring needle was instead of it.There was no patient contact.

• Brand Name: POWERPORT ISP MRI 6F CHRONW/OS
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13531323
• MDR Text Key: 285611115
• Report Number: 3006260740-2022-00317
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098963
• UDI-Public: (01)00801741098963
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/09/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 8806061
• Device Lot Number: REFP1563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 04/09/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 63 KG