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

Catalog Number 0605510CE

Device Problem Inaccurate Information (4051)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported that prior to a port placement procedure, the needle and the introducer contained in the set are allegedly not in conformity with the usual set.It was further reported that the reference and the lot present on the implant holder card contained in the set were allegedly not identical.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products are identified.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.(expiration date: 10/2025).

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 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 bardport titanium l/p implantable port kit was returned for evaluation.Gross visual evaluation was performed on the returned device kit.In addition to the physical sample received for evaluation, two electronic photos were provided for review.The first photo (img_9290.Jpg) shows product packaging label.The outer kit packaging box label contains catalog number (0605510ce), lot number(refv3935) and the list of components inside the kit.The second photo (img_9292.Jpg) shows a implant record which contains a catalog number (0655870), expiry date (2024-11-30) and lot number (reev2627).Both the details provided in the packaging label and implant record appears to be different and does not match with each other.Also, the exact circumstances at the time of package opening could not be verified from the provided photos.Hence, the reported issue cannot be confirmed.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 (expiration date: 10/2025).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 prior to a port placement procedure, the needle and the introducer contained in the set are allegedly not in conformity with the usual set.It was further reported that the reference and the lot present on the implant holder card contained in the set were allegedly not identical.The procedure was completed using another device.There was no patient contact.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 14050066
• MDR Text Key: 288856264
• Report Number: 3006260740-2022-01192
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050310
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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: 0605510CE
• Device Lot Number: REFV3935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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