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

Model Number 1708070

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2022).Device pending return.

Event Description

It was reported that prior to a port placement procedure, the device packing allegedly had a strand of hair.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.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 device was not returned for evaluation.Therefore, the reported package contamination issue cannot be confirmed.A definitive root cause could not be determined 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: 02/2022).H3 other text : device not returned.

Event Description

It was reported that prior to a port placement procedure, the device packing allegedly had a strand of hair.There was no reported patient contact.

• Brand Name: POWERPORT 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
• MDR Report Key: 10827912
• MDR Text Key: 215979630
• Report Number: 3006260740-2020-20467
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026652
• UDI-Public: (01)00801741026652
• Combination Product (y/n): N
• PMA/PMN Number: K060812
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1708070
• Device Catalogue Number: 1708070
• Device Lot Number: REER3725
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other