MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1616070

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 07/26/2021

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.(expiry date: 10/2021).

Event Description

It was reported that prior to a procedure, the package was allegedly found to be already opened.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 sealed powerport clearvue kit and outer packaging box was returned for evaluation.Gross visual evaluation was performed.The investigation is inconclusive for the reported unsealed device packaging issue, as the exact circumstances at the time of the reported event are unknown, and the reported event could not be reproduced in the lab.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 (expiry date: 10/2021).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 prior to a port placement procedure, the package was allegedly found to be opened already.There was no patient contact.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
• 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: 12357513
• MDR Text Key: 267813067
• Report Number: 3006260740-2021-03460
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026461
• UDI-Public: (01)00801741026461
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122899
• 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: 10/21/2021

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: 1616070
• Device Catalogue Number: 1616070
• Device Lot Number: REES3810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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