MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603880C

Device Problems Migration or Expulsion of Device (1395); Contamination /Decontamination Problem (2895)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 07/05/2020

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, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f 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 and photo was provided.The investigation of the reported event is currently underway.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.

Event Description

It was reported that some post port placement in right chest wall, the port placed in this patient fell off.A foreign matter was removed from the right atrium and the port was also removed by interventional department.The entire product was removed.The patient status was unknown.

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, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified in d2 and g5.H10: manufacturing review:a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned for evaluation, however, 4 electronic photos were provided for review.The investigation is inconclusive for catheter and port fell off issue as the exact circumstances at the time of the reported event cannot be confirmed from the provided photos.A definitive root cause could not be determined based upon available information.Labeling review:a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.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.

Event Description

It was reported that some time post port placement in right chest wall, the port placed in this patient fell off.A foreign matter was removed from the right atrium and the port was also removed by interventional department.The entire product was removed.The current patient status is stable.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10342866
• MDR Text Key: 201000470
• Report Number: 3006260740-2020-02705
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111167
• UDI-Public: (01)00801741111167
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603880C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 70