MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0602680

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/27/2023

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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2026).

Event Description

It was reported that during preparation of a port placement procedure, the hair was allegedly found inside the package.The procedure was completed by using another device.There was no patient contact.

Event Description

It was reported that during preparation of a port placement procedure, a hair was allegedly found inside the package.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 bardport implantable port kit was returned for evaluation.Gross visual evaluation was performed.In addition to the sample received, one photo was provided for review.Visual evaluation of the sample showed a hair, was found on the top center portion of the product tray tyvek label and the top right corner of the product tray tyvek label was noted to be partially detached.Manufacturing site evaluation of the product found that the lid had been completely detached from the outer tray revealing slight traces of transfer at the edge and it was observed on the surface of the lid of the inner tray there was a piece of hair that had been trapped between both lid.It was observed that the inner lid is slightly detached and a slight transfer of sealing was observed.Therefore the investigation is confirmed for the reported contamination issue, as a hair was found on the top center portion of the product tray tyvek label.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: 06/2026).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.

• Brand Name: M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 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: 16426256
• MDR Text Key: 310079245
• Report Number: 3006260740-2023-00522
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025679
• UDI-Public: (01)00801741025679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

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 Model Number: 0602680
• Device Catalogue Number: 0602680
• Device Lot Number: REFX1955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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