MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 7707540

Device Problems Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2021

Event Type  malfunction  

Manufacturer Narrative

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.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2023).

Event Description

It was reported that post port placement, the device allegedly failed to infuse.It was further reported that under x-ray, the catheter was broken near the neck of port.There was no reported patient injury.

Event Description

It was reported that post port placement, the device allegedly failed to infuse.It was further reported that under x-ray, the catheter was broken near the neck of port.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one x-port isp attached to a groshong catheter in two segments were returned for evaluation and one medical image was provided for review.Gross, microscopic visual and functional evaluations were performed.The investigation is inconclusive for the reported infusion problem as the exact circumstances at the time of reported event are unknown.However, the investigation is confirmed for the reported catheter fracture and the identified material separation issues, as a complete circumferential break was observed just distal to the cath-lock and the image review also confirms the same.Furthermore, the edges of the complete circumferential break were noted to be granular and smooth and two kinks were observed on the catheter approximately the 15cm depth mark and 9cm depth mark.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 05/2023), g3 h11: h6 (device, method, result, 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.H3 other text : see h10.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12243889
• MDR Text Key: 264046376
• Report Number: 3006260740-2021-02980
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027499
• UDI-Public: (01)00801741027499
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7707540
• Device Catalogue Number: 7707540
• Device Lot Number: REEZ1852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other