MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 7707540J

Device Problem Fracture (1260)

Patient Problem Death (1802)

Event Date 08/31/2020

Event Type  Death  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.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 x-port isp implantable port, groshong single-lumen, 8f only products that are cleared in the us.The pro code for the x-port isp implantable port, groshong single-lumen, 8f products is identified.

Event Description

It was reported that an alleged crack was noted on the syringe and leakage occurred.It was further reported that the patient expired.

Manufacturer Narrative

H10: manufacturing review:a device history record review could not be performed as the lot number is unknown.Investigation summary:one introducer needle and unknown 3cc syringe were received for evaluation.The sample was returned within protective tubing.Several cracks were noted to the hub.An in-house syringe was attached to the introducer needle with no issue.The needle was patent to infusion and aspiration.A leak from a crack was noted on the needle hub was noted.Electronic photos were also evaluated as part of this investigation.The investigation is confirmed for the observed cracks on the needle luer hub.The 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.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510k number for the x-port isp implantable port, groshong single-lumen, 8f products is identified in d2 and g5.H10: g4.H11: h6(result and conclusion).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 an alleged crack was noted on the introducer needle and leakage occurred.Reportedly the patient expired.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 10633347
• MDR Text Key: 209938083
• Report Number: 3006260740-2020-03453
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098246
• UDI-Public: (01)00801741098246
• Combination Product (y/n): N
• PMA/PMN Number: K022983
• 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: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7707540J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death