MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMEN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603880C

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo is provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f is identified in procode and pma/510k.(expiry date: 09/2022).

Event Description

It was reported that prior to a port placement procedure in the right chest wall via right subclavian vein the catheter allegedly found to have foreign material.It was further reported that the procedure was cancelled.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.Low-profile implantable port, hickmen single-lumen, 6.6f that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f is identified in d2 and g5.H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required investigation summary: the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is inconclusive for presence of foreign material issue as the exact circumstances at the time of reported event are unknown.Based upon the available information, the definitive root cause could not be determined.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: 09/2022).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.

Event Description

It was reported that prior to a port placement procedure in the right chest wall via right subclavian vein the catheter allegedly found to have foreign material.It was further reported that the procedure was cancelled.There was no patient contact.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMEN SINGLE-LUMEN, 6.6F
• 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
• MDR Report Key: 10827006
• MDR Text Key: 216361697
• Report Number: 3006260740-2020-20459
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603880C
• Device Lot Number: REDX4249
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 50