MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERFLOW APHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number A710962

Device Problem Unsealed Device Packaging (1444)

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

Event Date 04/20/2022

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 return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2022).

Event Description

It was reported that during preparation of a port placement procedure, the sterile box containing the product was allegedly unsealed.The procedure was completed by using another device.There was no patient contact.

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 unsealed powerflow implantable port kit.The following components were received: one powerflow implantable apheresis iv port, one catheter, one flushing connector, one syringe, one tunneler, one introducer needle, one bd insyte autoguard shielded iv catheter, one cath-lock, one j-tip guidewire in a guidewire hoop, and one 10f introducer peel-apart sheath with vessel dilator were returned for evaluation.In addition to the returned physical device two electronic photos were provided for review.The investigation is confirmed for the reported unsealed device packaging issue as the outer and inner tyvek labels were returned completely separated from the tyvek tray and seal transfer was noted throughout the border of the tyvek tray.Furthermore, the bd insyte autoguard shielded iv catheter packaging was noted to be open.A tear was noted to a styrofoam padding.A corner of the tyvek label was noted to be teared.The photo and manufacturing review also confirms the same.The definitive root cause of this complaint could not be determined the cause of this condition remains unknown.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: 11/2022), g3.H11: h6 (method, result, conclusion).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 during preparation of a port placement procedure, the sterile box containing the product was allegedly unsealed.The procedure was completed by using another device.There was no patient contact.

• Brand Name: POWERFLOW APHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F
• 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: 14351136
• MDR Text Key: 291349127
• Report Number: 3006260740-2022-01709
• Device Sequence Number: 1
• Product Code: PTD
• UDI-Device Identifier: 00801741129438
• UDI-Public: (01)00801741129438
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163001
• 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: 10/20/2022

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 Model Number: A710962
• Device Catalogue Number: A710962
• Device Lot Number: REFV0472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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