MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY; IMPLANTABLE PORT

Catalog Number 7707540J

Device Problems Break (1069); Dent in Material (2526)

Patient Problem Embolism (1829)

Event Date 12/25/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.A photo was provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to x-port isp plastic single lumen port that is cleared in the us the 510k number and pro code for x-port¿ isp plastic single lumen port.

Event Description

It was reported that because the patient complained of pain at the insertion site, an x ray image was taken an and alleged break was discovered.There was an alleged risk of catheter migration.The device was removed.The patient was reported as stable.

Event Description

It was reported that because the patient complained of pain at the insertion site, an x-ray image was taken and an alleged break was discovered.It was further reported that there was an alleged risk of catheter migration.The device was removed.The patient was reported as stable.

Manufacturer Narrative

H10: manufacturing review: neither a lot history review nor a dhr review could be performed as the lot number was not provided.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.Investigation summary: one electronic photo was evaluated.The photo shows two pieces of groshong catheter, a port and a cathlock, all disassembled.Blood can be seen all over the sample.There are two parallel lines on the septum of the port.One port with groshong catheter was returned for evaluation.Visual, microscopic, tactile and functional testing were performed.The sample had blood and fluid residue and showed to be the port, detached cath-lock, detached 7.3 cm length of interim catheter tubing and detached 7.6 cm length of distal catheter tubing.Initial examination of the port segment showed multiple puncture access and two extensive slits to the port septum, and location stains on the stem evidencing previous locations of the proximal end of tubing and cath-lock.Gross examination of the tubing segments showed tubing with clear and distinct depth markings, distinct slight curves, cath-lock compression marks on the interim segment confirming the proximal end between 14/15 depth markings and multiple partial circumferential securement creases on both.Further examination showed the common complete circumferentially shattered break ends of the tubing between the 7/8 cm depth markings to partially match up and exhibit flattened elliptical profiles.The tactile evaluation showed necking at the crease sites.The investigation is confirmed for the alleged break in the catheter.H11: b1, b5, g5, h3, h6 (device, results, 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.

• Brand Name: X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9708889
• MDR Text Key: 179454151
• Report Number: 3006260740-2020-00526
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• 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: 01/21/2020
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other