MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT TITANIUM ISP 6CF INT WSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8706060

Device Problems Fracture (1260); Suction Problem (2170); Obstruction of Flow (2423)

Patient Problems Pain (1994); Swelling (2091)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer and the evaluation is still pending.The investigation of the reported event is currently underway.Expiry date (08/2020).

Event Description

It was reported that one year five months post port placement the patient allegedly had pain and swelling around the catheter insertion point during slow flushing of saline.It was further reported that port allegedly was unable to aspirate blood prior to flushing.Reportedly the radiologist identified the catheter allegedly split and the port was successfully removed.The patient status was normal.

Manufacturer Narrative

H10: manufacturing review:a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: one powerport titanium isp with a catheter in two segments were returned for evaluation.The investigation is confirmed for the reported fracture as a longitudinal split was noted approximately 6.7cm from the distal end of the cath-lock.The edges of the longitudinal split were jagged.However, the investigation is inconclusive for the reported suction issue as the exact circumstances at the time of the reported event are unknown.A 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: 08/2020).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 one year five months post port placement the patient allegedly had pain and swelling around the catheter insertion point during slow flushing of saline.It was further reported that port allegedly was unable to aspirate blood prior to flushing.Reportedly the radiologist identified the catheter allegedly split and the port was successfully removed.The patient status was normal.

Event Description

It was reported that one year five months post port placement the patient allegedly had pain and swelling around the catheter insertion point during slow flushing of saline.It was further reported that port allegedly was unable to aspirate blood prior to flushing.Reportedly the radiologist identified the catheter allegedly split and the port was successfully removed.The patient status was normal.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: one powerport titanium isp with a catheter in two segments were returned for evaluation.The investigation is confirmed for the reported fracture as a longitudinal split was noted approximately 6.7cm from the distal end of the cath-lock.The edges of the longitudinal split were jagged.However, the investigation is inconclusive for the reported suction issue as the exact circumstances at the time of the reported event are unknown.A 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: 08/2020),g4.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: POWERPORT TITANIUM ISP 6CF INT WSP ATT SL
• 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: 10559473
• MDR Text Key: 207697434
• Report Number: 3006260740-2020-03316
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098871
• UDI-Public: (01)00801741098871
• Combination Product (y/n): N
• PMA/PMN Number: K072549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

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: 8706060
• Device Lot Number: RECV2159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 11/30/2020; 01/21/2021
• Supplement Dates FDA Received: 12/11/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR