MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARDPORT M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN VENOUS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602840
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the catheter could not be aspirated.The device was not used in/on the patient.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one mri port with groshong catheter kit was returned for evaluation.All listed components were returned except the right angle non-coring needle and one catheter lock.The sample appeared to be clean, though multiple punctures were observed to the port septum.The catheter was received with preloaded stylet inserted and was not attached to the port body.Both the port and catheter were patent to infusion and aspiration with no issues noted.Based on the findings, the investigation is unconfirmed for the reported failure to aspirate the catheter.Based on the received configuration, it is possible that aspiration through the stiffening stylet luer contributed to the reported event.Aspiration is not intended through this luer (as it is meant for flushing only) and should be checked following assembly onto the port stem.However, the definitive root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the reported event.Labeling review:the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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 or Problem Description
It was reported that the catheter could not be aspirated.The device was not used in/on the patient.

• Brand Name: BARDPORT M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN VENOUS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7874194
• Report Number: 3006260740-2018-02447
• Device Sequence Number: 186931
• Product Code: LJT
• UDI-Device Identifier: 00801741025730
• UDI-Public: (01)00801741025730
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2019

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
• Operator of Device: Health Professional
• Device Model Number: 0602840
• Device Catalogue Number: 0602840
• Device Lot Number: REYL1996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 01/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1