MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1716000

Device Problems Suction Problem (2170); Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 07/23/2020

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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 05/2020).

Event Description

It was reported that post port device placement, the patient allegedly experienced pain.The status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review:the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned to the manufacturer for evaluation.The investigation is inconclusive for the reported pain during flushing and no blood return, as the device was not returned for evaluation.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: b5,d4 (expiration date: 05/2020),g3,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.

Event Description

It was reported that ten months post port device placement, the patient allegedly experienced pain when port was flushed.It was further reported that swelling was observed in the device implant area.The device was replaced.The current status of the patient is unknown.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• 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: 10493015
• MDR Text Key: 205646599
• Report Number: 3006260740-2020-03168
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026744
• UDI-Public: (01)00801741026744
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

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: 1716000
• Device Catalogue Number: 1716000
• Device Lot Number: REDQ2851
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 11/27/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Weight: 27