MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems Extravasation (1842); Pain (1994); Rash (2033); Skin Erosion (2075)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 10/2019).

Event Description

It was reported that during a port removal procedure, the catheter was alleged fractured causing extravasation.It was further reported that the patient experienced skin burn near the insertion site.The procedure was completed using another device.The patient's current status was unknown.

Manufacturer Narrative

H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was not returned for evaluation; however, fifteen electronic photos were provided for review.All fifteen photos shows various timelines of the port implanted in the patient body.Skin or area near insertion site was looked burned and redness were noted in all of the provided photos.The investigation is inconclusive for the reported fracture and leak issue, as the device was not returned for evaluation and the provided photos is not evident to show any deficiencies with the device.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: b2, d4 (expiry date: 10/2019), g3, h6 (patient, method).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 during a port removal procedure, the catheter was alleged fractured causing extravasation.It was further reported that the patient experienced skin burn near the insertion site.The procedure was completed using another device.The patient's current status was unknown.

• Brand Name: POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL
• 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: 12056333
• MDR Text Key: 258024407
• Report Number: 3006260740-2021-02432
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• 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: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8808560
• Device Lot Number: REBY0773
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other