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

Model Number 1608052

Device Problems Difficult to Flush (1251); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Burning Sensation (2146)

Event Date 06/30/2021

Event Type  Injury  

Event Description

It was reported that post port placement procedure, the patient allegedly had internal bleeding.It was further reported that patient experienced pain and burning sensation while flushing the port with saline.The current patient status is unknown.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2021).

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport clearvue implantable port attached to a catheter was returned for evaluation and one electronic photo was provided for review.Gross visual, microscopic visual and functional evaluation were performed on the returned device.During functional evaluation, the port body with the attached catheter segment was unable to be aspirated.However, the investigation is inconclusive for the reported pain, bleeding and burning sensation problem as the exact circumstances at the time of the reported event are unknown.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.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 post port placement procedure, the patient allegedly had internal bleeding.It was further reported that patient experienced pain and burning sensation while flushing the port with saline.The current patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport clearvue implantable port attached to a catheter was returned for evaluation and one electronic photo and medical record were provided for review.Gross visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported difficulty in flushing, pain and bleeding issues.According to the medical record, approximately three months post port deployment, patient presented with internal bleeding.An angiogram revealed that no source of bleeding.Subsequently the clinician accessed the port, but not able to flush it with saline.While flushing it with saline patient noted with severe burning sensation from r clavicle to r carotid artery area.Clinician slowed the push, but the pain remains constant.Every time the port is accessed or de-accessed using a saline flush, the burning returned.Also, from the returned sample evaluation, a partial compound break was noted approximately 10.9cm from the distal end of the cath-lock.However, the identified fracture, wear and deformation issues were captured in another record, in this way in order to not duplicate the count of the appropriate codes in our records.Furthermore, clinical conditions such as burning alleged in the complaint cannot be confirmed.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: b5, d4 (expiry date: 03/2021).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 post port placement procedure, the device allegedly had difficulty in flushing.It was further reported that the patient allegedly had internal bleeding.Reportedly patient experienced pain and burning sensation while flushing the port with saline.The current patient status is unknown.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12867398
• MDR Text Key: 281198666
• Report Number: 3006260740-2021-05009
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026423
• UDI-Public: (01)00801741026423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2022

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 Model Number: 1608052
• Device Catalogue Number: 1608052
• Device Lot Number: REDX4225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/01/2021; 01/09/2022
• Supplement Dates FDA Received: 12/02/2021; 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female