MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. CHRONO PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0605420CE

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the m.R.I.Implantable port, chronoflex single-lumen, kit, 8f products that are cleared in the us.The pro code and 510k number for the m.R.I.Implantable port, chronoflex single-lumen, kit, 8f products is identified.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: 01/2025.

Event Description

It was reported that prior to the port placement procedure, the material information was allegedly different in primary and secondary packaging.There was no patient contact.

Event Description

It was reported that during preparation of a port placement procedure, the material information was allegedly different in primary and secondary packaging.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 m.R.I.Implantable port, chronoflex single-lumen, kit, 8f products that are cleared in the us.The pro code and 510k number for the m.R.I.Implantable port, chronoflex single-lumen, kit, 8f products is 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 x-port t/i l/p implantable port, one catheter, one flushing connector, two introducer needles, one straight non-coring needle, one right-angle non-coring needle, one cath-lock, one j-tip guidewire in a guidewire hoop, one straight guidewire in a guidewire hoop, one 6.5fr introducer peel-apart sheath and vessel dilator, one safety infusion set, one tunneler and one vessel dialator were returned for evaluation.Product packaging and label were returned, however the product label information does not match either material number and batch number listed.In addition to the physical sample received for evaluation, one electronic photo was provided for review.The photo shows 2 product packaging label.The outer kit packaging box label contains catalog number (0605420ce), lot number(refv0401) and the list of components inside the kit.The tyvek layer packaging label (secondary label) contains a catalog number (0655870), lot number (reev2627) and the information about micro introducer kit contents.Both the details provided in the packaging label appears to be different and does not match with the primary and secondary packaging.However, the investigation is inconclusive for the reported labeling problem issue as the exact circumstances at the time of package opening could not be verified from the provided photos and the received physical sample.Hence, the reported issue cannot be confirmed.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: b5, d4 (expiry date: 01/2025).H11: section a through f ¿ the information provide 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.H3 other text : see h10.

• Brand Name: M.R.I. CHRONO 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13281877
• MDR Text Key: 283961672
• Report Number: 3006260740-2021-05662
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K873213
• 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: 06/09/2022

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: 0605420CE
• Device Lot Number: REFV0401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2021
• 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