MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1716000J

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/31/2023

Event Type  malfunction  

Event Description

It was reported that prior to the port placement procedure, before the device was delivered to the hospital it was allegedly found to be contaminated with a foreign material.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the power port slim implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport slim implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.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.H10: d4 (expiry date: 11/2024).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 : 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 power port slim implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport slim implantable port, chronoflex single-lumen, 6f products are 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 unsealed powerport slim implantable port kit in its original packaging was returned for evaluation.Gross visual evaluation was performed.The kit appeared to be clean.Kit was inspected thoroughly.What appeared like brown foreign material, was noted within the package, below the tyvek product label and on the back of the packaging plastic.Manufacturing review also confirms the presence of foreign material.Therefor the investigation is conformed for the reported foreign material issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 11/2024).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.

Event Description

It was reported that prior to a port placement procedure, before the device was delivered to the hospital, it was allegedly found to be contaminated with a foreign material.There was no patient contact.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 17602308
• MDR Text Key: 321722744
• Report Number: 3006260740-2023-03647
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111631
• UDI-Public: (01)00801741111631
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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: 1716000J
• Device Lot Number: REHN2160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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