MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603870C

Device Problems Suction Problem (2170); Detachment of Device or Device Component (2907); Scratched Material (3020); Migration (4003)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products is identified.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Medical device expiry date - 11/2022.Device not returned.

Event Description

It was reported that post port device placement through the right internal jugular vein on the right chest wall, the device was unable to return blood during chemotherapy.Upon inspection it was allegedly found that the latch of the port was detached and had migrated to the pulmonary artery.The detachment was recovered.The current patient status is unknown.

Event Description

It was reported that post port device placement through the right internal jugular vein on the right chest wall, the device was found to be unable to return blood during chemotherapy.Upon inspection it was allegedly found that the latch of the port was detached and had migrated to the pulmonary artery.The detachment was recovered.The current patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one mri low profile port and one catheter lock was returned for evaluation.Functional, gross visual, microscopic visual and dimensional evaluations were performed.The investigation is inconclusive for the reported unable to aspirate, detachment and migration issue, as the exact circumstances at the time of the reported event are unknown and the reported event could not be reproduced in the lab.The investigation is confirmed for the identified scratched material issue, as tool damage was noted to the cath-lock.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.Based upon the available information a 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: 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, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products are identified in d2 and g5.H10: d4 (expiry date: 11/2022), g3.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.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F
• 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: 10711360
• MDR Text Key: 212291606
• Report Number: 3006260740-2020-20201
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603870C
• Device Lot Number: REDZ0872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 60