MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SMTI PRT ATT 6.6F OPN DAIG; IMPLANTABLE PORT

Catalog Number 0606100C

Device Problem Break (1069)

Patient Problem Embolism (1829)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

The lot number of the device was provided.The device history records are currently under review.The return of the sample is pending.An x-ray image was provided for review.The catalog number identified has not been cleared in the us but is similar to the titanium low-profile single lumen port.That is cleared in the us.The 510k/pma number and pro code for the titanium low-profile single lumen port is identified.The investigation is currently underway.Medical device - expiry date: 09/2020.

Event Description

It was reported approximately two months post port placement in the right internal jugular vein that the device allegedly failed to aspirate.It was further reported that x-ray imaging allegedly showed a broken port, and the catheter had migrated to the superior vena cava.Reportedly, the device was removed and replaced.The patient was reported as stable.

Manufacturer Narrative

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: the sample was not returned for evaluation, however an image was provided for review.The image review could not confirm a migration of the catheter into the superior vena cava.Therefore, the investigation remains inconclusive due to the lack of a returned device.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.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.H10: d4 (expiry date: 09/2020); 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 approximately two months post port placement in the right internal jugular vein that the device allegedly failed to aspirate.It was further reported that x-ray imaging allegedly showed a broken port, and the catheter had migrated to the superior vena cava.Reportedly, the device was removed and replaced.The patient was reported as stable.

• Brand Name: SMTI PRT ATT 6.6F OPN DAIG
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9356289
• MDR Text Key: 167423168
• Report Number: 3006260740-2019-03642
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111181
• UDI-Public: (01)00801741111181
• Combination Product (y/n): N
• PMA/PMN Number: K050310
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0606100C
• Device Lot Number: REBW1289
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 55